| Job List |
| Job ID: |
DS-03268-1 - Sr. Clinical Project Manager |
| Description: |
This Company develops and markets advanced medical devices that help healthcare professionals treat patients more effectively. For the last 150 years, this Company has developed advanced medical devices for healthcare professionals around the world.
This company is currently looking for a Sr. Clinical Project Manager
Job Description
You will be responsible for the management of regulated and scientific clinical trials and will be expected to:
(a) Develop clear measurable project timelines with milestones,
(b) Manage contract negotiations with sites and other study business partners, (c) Develop and manage study budgets
(d) Review/prepare FDA trial submissions,
(e) Develop protocols,
(f) Interact with site Investigators and staff, and
(g) Implement and oversee all aspects of study management.
You must have the ability to form and motivate cross functional groups in order to accomplish project related objectives. You will work with management and staff in all areas. Medical device experience a plus.
Travel both domestic and international required 30% of the time.
Candidate Must Have :
- Bachelors degree with a major in life sciences, nursing, medical technology or related area. (Masters preferred)
- Minimum of five (5) years clinical affairs or related experience plus two (2) years of prior healthcare. Four (4) years of experience required with a Masters degree
- Extensive knowledge of FDA and IDE
Relocation is allowed and will be discussed during the interview process
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 5 Yrs,
Start Date: ASAP,
Location: Memphis, TN |
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| Job ID: |
PCR-12207-1 - Associate Clinical Project Manager |
| Description: |
Position Description and Responsibilities:
The Clinical Project Manager is responsible for independently managing and overseeing all operational aspects of nutritional clinical trials. The incumbent will ensure that clinical trial data in support of regulatory submission and product messaging are of high quality and valid. Responsibilities will include, but will not be limited to:
Participating in the design and development of clinical study protocols and Case Report Forms (CRFs).
Conducting investigator identification, selection, evaluation, initiation, and training.
Managing protocol approval process, including IRB/Ethics Board submission and approvals.
Managing contract clinical monitors to ensure monitoring efforts meet established timelines and deliverables.
Developing and negotiating site budgets.
Serving as the lead Sponsor contact for resolving site related issues.
Managing projects by coordinating activities and organizational entities to keep projects on established timelines.
Generating project documentation (including but not limited to) project specifications, project reports, communication records (logs), meeting agendas and minutes, and status reports.
Position Requirements and Necessary Skills:
Thorough knowledge of ICH and GCP guidelines for clinical research.
Ability to identify deviations from project plan and to work with project team and management to develop corrective action plans.
Ability to work in a team environment.
Ability to understand and review detailed clinical reports.
Knowledge of project management tools and practices.
Ability to manage multiple projects at varying stages of completion.
Effective in setting and meeting personal short- and long-term goals to complete assignments.
Ability to anticipate problems relating to projects and to develop and implement solutions.
Excellent communication and organizational skills.
Solid leadership skills.
Strong MS Office skills.
Qualifications and Experience:
BA/BS, preferably in a scientific field, or equivalent knowledge gained through experience working in a scientific area.
At least 4 years of clinical research experience including field monitoring of clinical trials.
Thorough understanding of traditional CRA skills (site identification, monitoring, tracking, data collection and cleaning)
Practical experience of clinical trial methodology (study design).
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Salary: 70-90k,
Job Type: Permanent,
Total Exp: 3 Yrs ,
Start Date: ASAP,
Location: Evansville, IN |
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| Job ID: |
TB-07277-2 - Associate Director/ Director Clinical Affairs |
| Description: |
Summary
Provide leadership and supervision to the Clinical Affairs group in NY office. Responsibilities include client interaction; defining project requirements, deliverables, schedules and budgets; managing project schedules and budgets; promoting SOP and policy compliance; monitor resource needs; staff management, promoting the use of tools and metrics.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Develop and manage the project management department including, but not limited to the following
areas.
Manage:
-Consistency of project management and clinical monitoring regarding project requirements, deliverables, schedules and budgets.
-Communication with clients and Client Project Managers to promote project schedule adherence, ensure that projects are adequately staffed with personnel and resources, and meet high quality standards.
-Development and maintenance of operations and procedure manuals, work guidelines, department metrics and project tools.
Coordinate training and education programs to ensure staff is trained as needed, including but not limited to relevant therapeutic areas, ICH guidelines, and regulatory requirements
Assist with managing and monitoring the departmental budget. Monitor department billable percentages.
Work closely with clinical project managers to promote operational efficiency, teamwork, and high morale.
Interact with clients in a customer service role and to ensure solid team relations.
Collaborate with staff inter and intra-departmentally on the proposal development process.
Assist in Operations meetings and directives to improve department and corporate policies and procedures.
Supervise projects involving monitoring, database management, data management/entry, programming, statistics, report writing, and agency presentations.
Make presentations and represent company at professional meetings and to prospective and existing clients.
Manage personnel activities, and provide guidance for professional development of staff (coordinate resource distribution across projects, interviews, makes hiring recommendations, leads disciplinary actions, delivers performance reviews.)
Additional Duties and Responsibilities:
Act as back-up for project managers.
Qualification Requirements: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions.
Education and/or Experience:
BS/BA. 5 years industry experience including and at least 5 years clinical trial experience; minimum 5 years project and /or team management experience.
Other Skills and Abilities:
Must have strong leadership and management skills. Must have the ability to handle multiple projects simultaneously and manage multi-functional teams; must have creative problem solving skills; excellent verbal / written communication skills. Must have strong computer skills. Must have strong time management and organizational skills. Must have excellent knowledge of at least two departmental processes and functions within the Pharmaceutical Industry and drug development process.
Preferred Qualifications
Advanced degree; 5+ years project management experience within a CRO; 5+-years management experience.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Some stress may occur. Some travel may be required. No special physical demands required.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This is an in-house position.
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Salary: 120-145K,
Job Type: Permanent,
Total Exp: 5+ Yrs,
Start Date: ASAP,
Location: Rye Brook, NY |
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| Job ID: |
CLM-09277-5 - Associate Director/Director, Project Management |
| Description: |
ESSENTIAL JOB FUNCTIONS: Manage Program Managers and Regional Project Managers
Management and prioritization of client resourcing in conjunction with Directors of US, Canadian, and European Operations
Collaboration with Business Development staff to ensure client proposals are consistent with Clinimetrics capabilities
Participation on corporate Project Management Team to standardize global, full-service project management procedures and systems
JOB REQUIREMENTS / EDUCATION / EXPERIENCE:
Masters level degree (e.g. MBA, MHA, MSN) preferred
Minimum 10 years clinical research experience or equivalent, including three years prior project management experience
Demonstrated management skills
Excellent communications skills
Solid collaboration and negotiation skills
Ability to multi-task and problem solve
Excellent interpersonal skills
Strong leadership skills
Thorough knowledge of medical and pharmaceutical industry, terminology, and practices
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Salary: 90110k,
Job Type: Permanent,
Total Exp: 10+ Yrs,
Start Date: ASAP,
Location: Atlanta, GA |
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| Job ID: |
CLM-01038-1 - Clinical Project and Program Managers |
| Description: |
If you are a leader and team builder, and you believe in customer service, then read on:
Purpose of Position:
My client is looking for Clinical Project Managers, Clinical Program Managers and Sr. CRAs who are looking to grow and take on a higher level of management responsibilities of our clinical trial projects.
Requirements and Responsibilities:
-Ensure integration of functional service areas.
-Serve as the liaison between Clinimetrics and our clients.
-Ensure adequate project staffing, monitoring and adherence to project budget, and invoicing review.
-Collect, review and maintain regulatory documentation.
-Develop protocol and ensure compliance.
-Develop case report forms.
-Train and supervise project teams.
-Prepare client reports.
-Ensure compliance with project objectives and problem resolution.
-Assist Business Development personnel in defining strategies to increase revenues for assigned client(s).
-Serve as mentor for Project Managers.
-Excellent problem solving skills.
-Excellent interpersonal and communication skills.
Education & Experience:
Candidates for Project Manager must possess a B.S. in biological sciences or related field plus a minimum of 3 years clinical research experience.
Candidates for Program Manager positions must possess an RN or Bachelor's degree in biological sciences or related field with 6 years pharmaceutical industry research experience, including two years experience managing clinical trials or equivalent.
Travel:
Some travel may be required.
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Salary: Open,
Job Type: Permanent,
Total Exp: 3+ Yrs,
Start Date: ASAP,
Location: East Coast |
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| Job ID: |
CLM-01038-2 - Clinical Project and Program Managers |
| Description: |
If you are a leader and team builder, and you believe in customer service, then read on:
Purpose of Position:
My client is looking for Clinical Project Managers, Clinical Program Managers and Sr. CRAs who are looking to grow and take on a higher level of management responsibilities of our clinical trial projects.
Requirements and Responsibilities:
-Ensure integration of functional service areas.
-Serve as the liaison between Clinimetrics and our clients.
-Ensure adequate project staffing, monitoring and adherence to project budget, and invoicing review.
-Collect, review and maintain regulatory documentation.
-Develop protocol and ensure compliance.
-Develop case report forms.
-Train and supervise project teams.
-Prepare client reports.
-Ensure compliance with project objectives and problem resolution.
-Assist Business Development personnel in defining strategies to increase revenues for assigned client(s).
-Serve as mentor for Project Managers.
-Excellent problem solving skills.
-Excellent interpersonal and communication skills.
Education & Experience:
Candidates for Project Manager must possess a B.S. in biological sciences or related field plus a minimum of 3 years clinical research experience.
Candidates for Program Manager positions must possess an RN or Bachelor's degree in biological sciences or related field with 6 years pharmaceutical industry research experience, including two years experience managing clinical trials or equivalent.
Travel:
Some travel may be required.
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Salary: Open,
Job Type: Permanent,
Total Exp: 3+ Yrs,
Start Date: ASAP,
Location: Atlanta, GA |
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| Job ID: |
CLM-09287-3 - Clinical Project Manager |
| Description: |
If you are a leader and team builder, and you believe in customer service, then read on:
Project Management is essential to successful and efficient drug and product development. It is our strong belief that the Project Manager is the central figure, the clients point of contact, and the champion for each project, regardless of its size or complexity. The Project Manager is the leader of a multi-disciplinary team of clinical research professionals brought together to successfully complete the program. We place a high value on the relationship between the Project Manager and our clients. Our Project Management staff is widely distributed internationally, and the project manager will be located in close proximity.
The Project Manager is responsible for:
Strategic planning for the project
Primary liaison with the client and coordination of project team members
Identification and management of the study management team
Delivery of integrated services, project tracking/metrics, project finances and project deliverables
Is the contact liaison and advocate
Identifies, establishes and globally integrates the Study Management Team
Ensures timelines are met
Prepares Gantt charts for management of the project
Reports on study status as frequently as clients request
Proactively tracks budget and scope changes and coordinates vendors
Requirements and Responsibilities:
-Ensure integration of functional service areas.
-Serve as the liaison between Company and clients.
-Ensure adequate project staffing, monitoring and adherence to project budget, and invoicing review.
-Collect, review and maintain regulatory documentation.
-Develop protocol and ensure compliance.
-Develop case report forms.
-Train and supervise project teams.
-Prepare client reports.
-Ensure compliance with project objectives and problem resolution.
-Assist Business Development personnel in defining strategies to increase revenues for assigned client(s).
-Serve as mentor for Project Managers.
-Excellent problem solving skills.
-Excellent interpersonal and communication skills.
Education & Experience:
Candidates for Project Manager must possess a B.S. in biological sciences or related field plus a minimum of 3 years clinical research experience.
Candidates for Program Manager positions must possess an RN or Bachelor's degree in biological sciences or related field with 6 years pharmaceutical industry research experience, including two years experience managing clinical trials or equivalent.
Travel:
Some travel may be required.
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Salary: to 98k + Bonus,
Job Type: Permanent,
Total Exp: 3+ Yrs,
Start Date: ASAP,
Location: Atlanta. GA |
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| Job ID: |
CM-02278-1 - Clinical Project Manager |
| Description: |
Duties and Responsibilities
-Manage the investigative sites by discussing and resolving protocol, budget, enrollment and staffing issues.
-Direct and interact with the Clinical Research Associates (CRAs) and Project Coordinator to ensure that the project is properly monitored, and data is accurate and collected uniformly between the various investigative sites.
-Direct outside vendors including consultants and CROs with respect to the clinical trials.
-Prepare and review protocols, reports, and other study information.
-Prepare and review SOPs and ensure that procedures are appropriately and consistently applied to all study activities.
-Responsible for the successful completion and regulatory rigor of all clinical studies.
-Responsible to the timely completion of all clinical studies.
-Responsible for adequate training of clinical staff.
-Other responsibilities include: Investigator Payments, Study Tracking, and Study Files.
-Overnight travel required.
Requirements:
Clinical degree.
Minimum of 5 years Project Management of Oncology studies.
Ability to manage timelines, budgets and CRAs and outside vendors.
Previous experience as a CRA.
MS Word, Excel, Medical/Regulatory Terminology.
Excellent communication skills (oral and written) a must.
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Salary: to 110k,
Job Type: Permanent,
Total Exp: 3-5 Yrs,
Start Date: ASAP,
Location: Norristown, PA |
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| Job ID: |
LP-05028-2 - Clinical Project Manager |
| Description: |
Responsibilities:
Manage the investigative sites by discussing and resolving protocol, budget, enrollment and staffing issues.
Ensure that project status information is collected and distributed to the Luitpold team.
Direct and interact with the Clinical Research Associates (CRAs) and Project Coordinator to ensure that the project is properly monitored, and data is accurate and collected uniformly between the various investigative sites.
Direct outside vendors including consultants and CROs with respect to the clinical trials.
Prepare and review protocols, reports, and other study information.
Prepare and review SOPs and ensure that procedures are appropriately and consistently applied to all study activities.
Responsible for the successful completion and regulatory rigor of all clinical studies.
Responsible to the timely completion of all clinical studies.
Responsible for adequate training of clinical staff.
Other responsibilities include: Investigator Payments, Study Tracking, and Study Files.
Overnight travel required.
Requirements:
Clinical degree.
Minimum of 5 years Project Management of Oncology studies.
Ability to manage timelines, budgets and CRAs and outside vendors.
Previous experience as a CRA.
MS Word, Excel, Medical/Regulatory Terminology.
Excellent communication skills (oral and written) a must.
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Salary: 100-110k,
Job Type: Permanent,Contract,
Total Exp: 5 Yrs,
Start Date: ASAP,
Location: Philadelphia Area |
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| Job ID: |
TB-01158-6 - Clinical Project Manager |
| Description: |
Position Summary:
Under minimal supervision, the Project Manager acts as the liaison between the Sponsor and team members including regional CRAs, and sites while managing projects to ensure quality service. Responsibilities encompass the overall management of a project including budgeting, scope, timeline adherence, internal and external communications, and project deliverables. Serve as point of contact for internal and external customers for assigned projects.
Position responsibilities include:
Define project requirements, deliverables, schedules and budgets.
Manage projects that may include monitoring, database development and maintenance, data management/entry, programming, statistics, report writing, and agency presentations.
Maintain close communications with clients and team members and managers to ensure that projects remain on schedule and within budget, are adequately staffed with personnel and resources, and meet high quality standards.
Work closely with staff members both intra- and inter-departmentally to promote operational efficiency, teamwork, and high morale.
Proactively identify issues and develop strategies for assuring study timelines are met and assuring quality deliverables.
Document project-specific procedures and processes.
Manage the preparation and distribution of materials for project and sponsor meetings.
Manage lead project/sponsor meetings, provide follow-up of action items.
Manage project start-up activities, and oversee distribution of project documents.
Manage the oversight of preparation and maintenance of Central and Site Files for projects.
Manage and review the data entry of subject tracking information for the production of enrollment and monthly reports.
Manage the planning and coordination of investigator meetings when contracted to do so.
Identify out-of-scope tasks and client requests and assist with writing work assignments as needed.
Delegate tasks to Clinical Project Associates and other team members as appropriate; oversee task performance and completion.
Maintain regular contact with study sites to ensure protocol/GCP compliance, assess patient accrual rates, and respond to sponsor requests.
Develop and maintain operations and procedures manuals as required.
Help train and possibly oversee project management staff including Clinical Project Associates and Project Assistants.
For any project issues, work with team members and the sponsor to help resolve issues in a timely and effective manner.
Provide monthly financial reports, including ETCs, as required.
Qualified applicants will have:
Bachelors degree or equivalent combination of education and experience, including course work in health related field.
Minimum 3-5 years experience working within the pharmaceutical/biotech industry.
Must have creative problem solving skills; very strong written and verbal communication skills.
Must have strong knowledge of Good Clinical Practices.
Must have professional demeanor and appearance.
Excellent time management and organizational skills with ability to work in a high volume and strict deadline environment
Proficiency in operating computer applications and navigating the internet
Excellent interpersonal skills
Ability to work independently
Preferred Qualifications:
Project Management or Clinical Monitoring experience; 1-year management experience preferred.
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Salary: 90-95K,
Job Type: Permanent,
Total Exp: 3-5 Yrs,
Start Date: ASAP,
Location: Southborough, MA |
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| Job ID: |
CLM-09187-1 - Clinical Project Manager - Oncology |
| Description: |
If you are a leader and team builder, and you believe in customer service, then read on:
Project Management is essential to successful and efficient drug and product development. It is our strong belief that the Project Manager is the central figure, the clients point of contact, and the champion for each project, regardless of its size or complexity. The Project Manager is the leader of a multi-disciplinary team of clinical research professionals brought together to successfully complete the program. We place a high value on the relationship between the Project Manager and our clients. Our Project Management staff is widely distributed internationally, and the project manager will be located in close proximity.
The Project Manager is responsible for:
Strategic planning for the project
Primary liaison with the client and coordination of project team members
Identification and management of the study management team
Delivery of integrated services, project tracking/metrics, project finances and project deliverables
Is the contact liaison and advocate
Identifies, establishes and globally integrates the Study Management Team
Ensures timelines are met
Prepares Gantt charts for management of the project
Reports on study status as frequently as clients request
Proactively tracks budget and scope changes and coordinates vendors
Requirements and Responsibilities:
-Experience in Oncology Trials
-Ensure integration of functional service areas.
-Serve as the liaison between Company and clients.
-Ensure adequate project staffing, monitoring and adherence to project budget, and invoicing review.
-Collect, review and maintain regulatory documentation.
-Develop protocol and ensure compliance.
-Develop case report forms.
-Train and supervise project teams.
-Prepare client reports.
-Ensure compliance with project objectives and problem resolution.
-Assist Business Development personnel in defining strategies to increase revenues for assigned client(s).
-Serve as mentor for Project Managers.
-Excellent problem solving skills.
-Excellent interpersonal and communication skills.
Education & Experience:
Candidates for Project Manager must possess a B.S. in biological sciences or related field plus a minimum of 3 years clinical research experience.
Candidates for Program Manager positions must possess an RN or Bachelor's degree in biological sciences or related field with 6 years pharmaceutical industry research experience, including two years experience managing clinical trials or equivalent.
Travel:
Some travel may be required.
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Salary: to 98k + Bonus,
Job Type: Permanent,
Total Exp: 3+ Yrs,
Start Date: ASAP,
Location: All US Locations |
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| Job ID: |
DS-01318-2 - Clinical Project Manager-Cardiovascular |
| Description: |
This Contract Services Organization is a global CRO headquartered in Rockville, MD. They are focused on cardiovascular, renal, and metabolic clinical development programs for the pharmaceutical and biotech industry. This company offers project and data management, clinical site monitoring, biostatistical analysis, and regulatory support for companies involved in Phase II through Phase IV drug studies. They are a growing company with a good reputation in Clinicals.
They are currently seeking a Clinical Project Manager-Cardiovascular
Position Description:
The Project Manager (PM) leads the project team in development strategy design process and its execution for a clinical trial, optimizing metrics including risk, cost, quality, and time tradeoffs consistent with a sponsors objectives. Monitors the project development process and ensures that key requirements and milestones are identified and met. Serves as the point-of-contact for cross-functional communication and tracking.
Responsibilities:
Develops a broad knowledge of the cardiovascular therapeutic environment and drug/device development trends.
Leads project team in designing and executing development plan for a project.
Leads project team in developing common mission, goals, commitment, and standards of behavior.
Collaborates with sponsors to ensure that all relevant scientific issues and opportunities are addressed in project plan.
Assures that the conduct of assigned clinical research studies are completed in accordance with relevant corporate SOPs, FDA and local regulations, and GCP/ICH guidance documents.
Manages resource constraints, risks, and conflicts, which could impact the project timeline, quality, or budget. Develops and implements plans to minimize their impact.
Manages cross functional groups to ensure effective communication, and on-time, on-budget completion of contracted tasks.
Coordinates the management of all financial aspects of the clinical trial with other project team members, including budget expenditures and change orders.
Reviews original budget tracker for compliance with scope of work and then maintaining the budget tracker on a monthly basis.
Participates in proposal development and in investigator and sales presentations.
Documents project teams activities accurately through minutes, plans, and recommendations.
Manages the project team to complete all contracted tasks, including activities associated with third-party vendors and internal functional groups.
Other relevant duties assigned for which the incumbent is qualified.
Education and Experience:
Bachelors Degree in a related scientific or technical area (RN preferred) and four years of experience in the management of clinical projects.
Demonstrated the ability to manage budgets and personnel.
Demonstrated the ability to work successfully in a team environment requiring matrix management.
Demonstrated the ability to evaluate and critique scientific reports and literature relative to drug and device development.
Demonstrated the knowledge of FDA regulations and requirements governing the conduct of clinical trials including GCP and ICH.
Demonstrated ability to make effective presentations in public settings.
Demonstrated ability to interact with clients on sensitive issues and handle concerns appropriately.
Experience with team building and conflict resolution desirable
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Salary: 70-90k,
Job Type: Permanent,
Total Exp: 2+ Yrs,
Start Date: ASAP,
Location: Mid West & East Coast |
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| Job ID: |
TB-03038-1 - Director, Project Management |
| Description: |
Position Summary
The Director, Project Management (DPM) provides direction, strategic management, oversight, training and support to the clinical research Project Directors (PD), Project Managers (PM) and their teams to ensure that company delivers quality projects to its clients, and achieves or exceeds clinical trials project goals. As a seasoned project manager the incumbent provides industry expertise and leadership to project managers on multiple and complex national and international clinical trials, typically in phases II-III. The Director, Project Management acts as the point of escalation between the client and the project team to ensure a successful outcome while strengthening the client relationship. The DPM is responsible for maintaining continuous process improvements and for ensuring adherence to operational excellence, timelines, safety and quality measures, and revenue recognition/forecasting for a portfolio of clinical trials projects.
Position Qualifications
Minimum of a Bachelors degree in a science, health field or industry related discipline required; advanced degree in related discipline or business preferred.
Minimum 10-15 years industry related experience with at least 5 years in project management preferably in a CRO or pharmaceutical company.
Must have strong clinical trials experience, knowledge of the key factors involved in effectively servicing and managing the relationship with pharmaceutical and/or biotechnology companies.
Proven record of strong supervisory/management and leadership skills.
Demonstrated success with operational/process driven improvements.
Record of results orientation with demonstrated drive to meet targets, and act decisively to ensure completion of projects and growth of business.
Team player with outstanding interpersonal skills.
Broad business expertise.
Client focused approach to work with track record of excellent stakeholder/relationship management skills.
Excellent presentation, persuasive verbal and written communication skills, with ability to influence others.
Excellent organizational skills with the ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail.
Strong business acumen and skills in matters related to resource management and revenue enhancement.
Solid knowledge of industry regulatory laws, ICH regulations, and GCP.
Ability to role-model leadership behaviors and the highest level of business ethics.
Flexibility with respect to work assignments, new learning and travel.
Willingness to work with multiple stakeholders in a matrix and global environment.
Experience with Microsoft based applications and general knowledge of PC functions.
Location and Travel
Opportunities exist in San Diego, CA.
Incumbents typically travel approximately 25%.
Salary Target $130-150K, based on experience and up to 15% Management Incentive Bonus eligible
Ideal Candidate
Experience with direct-line management of others, preferably in a clinical research environment, such as another CRO.
Pharmaceutical experience working with CROs or outsourced vendors helpful.
Experience or demonstrated success in client-focused environment (e.g., consulting or CRO).
Financial acumen to oversee budget management, and conduct strategic planning revenue forecasting.
Should have business development experience.
Experience in strategic or leadership position.
Experience managing portfolio of clinical trial projects or programs through others.
May have extensive pharmaceutical experience managing vendors and CROs??
Is a polished presenter whose presence with sponsor/client would add value to position.
Strategic/big-picture thinker.
Confidence needed for situations such as bid defense.
Can be a therapeutic generalist.
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Salary: 130K + 15%,
Job Type: Permanent,
Total Exp: 5+ Yrs,
Start Date: ASAP,
Location: San Diego, CA |
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| Job ID: |
CLM-09187-2 - Project Associate Supervisor |
| Description: |
Requirements and Responsibilities:
Daily supervision and mentoring of assigned staff
Study Management Team and key meeting attendance
Coordination of training needs with client specific and preferred provider programs
Ensure quality of Project Associate deliverables
Responsible for budget management
Management of small, single projects
Completion and timely delivery of quality project tasks and responsibilities
Management of group project support activities
Dissemination of study information to project study team
Education & Experience:
BA, BS or equivalent in a scientific or healthcare discipline or working towards such degree
4-5 years direct project related experience in the pharmaceutical or healthcare industry
Working knowledge of clinical research procedures and practices including GCP/ICH
Strong written and verbal communication skills
Ability to multi-task, meet deadlines and milestones, with quality deliverables
Ability to work well with inter-department personnel as well as clients
Strong interpersonal, communication and organization skills
Strong computer skills and knowledge to include electronic mail, Microsoft Word and Excel and MS Project
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Salary: to 98k + Bonus,
Job Type: Permanent,
Total Exp: 4-5 Yrs,
Start Date: ASAP,
Location: San Jose, San Diego |
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| Job ID: |
CLM-02068-1 - Regional Clinical Project Manager - Oncology |
| Description: |
Home Based west of the Rockies.
If you are a leader and team builder, and you believe in customer service, then read on:
Project Management is essential to successful and efficient drug and product development. It is our strong belief that the Project Manager is the central figure, the clients point of contact, and the champion for each project, regardless of its size or complexity. The Project Manager is the leader of a multi-disciplinary team of clinical research professionals brought together to successfully complete the program. We place a high value on the relationship between the Project Manager and our clients. Our Project Management staff is widely distributed internationally, and the project manager will be located in close proximity.
The Project Manager is responsible for:
Strategic planning for the project
Primary liaison with the client and coordination of project team members
Identification and management of the study management team
Delivery of integrated services, project tracking/metrics, project finances and project deliverables
Is the contact liaison and advocate
Identifies, establishes and globally integrates the Study Management Team
Ensures timelines are met
Prepares Gantt charts for management of the project
Reports on study status as frequently as clients request
Proactively tracks budget and scope changes and coordinates vendors
Requirements and Responsibilities:
-Experience in Oncology Trials
-Ensure integration of functional service areas.
-Serve as the liaison between Company and clients.
-Ensure adequate project staffing, monitoring and adherence to project budget, and invoicing review.
-Collect, review and maintain regulatory documentation.
-Develop protocol and ensure compliance.
-Develop case report forms.
-Train and supervise project teams.
-Prepare client reports.
-Ensure compliance with project objectives and problem resolution.
-Assist Business Development personnel in defining strategies to increase revenues for assigned client(s).
-Serve as mentor for Project Managers.
-Excellent problem solving skills.
-Excellent interpersonal and communication skills.
Education & Experience:
Candidates for Project Manager must possess a B.S. in biological sciences or related field plus a minimum of 3 years clinical research experience.
Candidates for Program Manager positions must possess an RN or Bachelor's degree in biological sciences or related field with 6 years pharmaceutical industry research experience, including two years experience managing clinical trials or equivalent.
Travel:
Some travel may be required.
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Salary: Open,
Job Type: Permanent,
Total Exp: 3+ Yrs,
Start Date: ASAP,
Location: East of The Rockies |
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| Job ID: |
PCR-05068-5 - Sr. Clinical Project Manager |
| Description: |
The Project Manager is responsible for:
Strategic planning for the project
Primary liaison with the client and coordination of project team members
Identification and management of the study management team
Delivery of integrated services, project tracking/metrics, project finances and project deliverables
Is the contact liaison and advocate
Identifies, establishes and globally integrates the Study Management Team
Ensures timelines are met
Prepares Gantt charts for management of the project
Reports on study status as frequently as clients request
Proactively tracks budget and scope changes and coordinates vendors
Requirements and Responsibilities:
-Ensure integration of functional service areas.
-Serve as the liaison between Company and clients.
-Ensure adequate project staffing, monitoring and adherence to project budget, and invoicing review.
-Collect, review and maintain regulatory documentation.
-Develop protocol and ensure compliance.
-Develop case report forms.
-Train and supervise project teams.
-Prepare client reports.
-Ensure compliance with project objectives and problem resolution.
-Assist Business Development personnel in defining strategies to increase revenues for assigned client(s).
-Serve as mentor for Project Managers.
-Excellent problem solving skills.
-Excellent interpersonal and communication skills.
Education & Experience:
Candidates for Project Manager must possess a B.S. in biological sciences or related field plus a minimum of 3 years clinical research experience.
Candidates for Program Manager positions must possess an RN or Bachelor's degree in biological sciences or related field with 6 years pharmaceutical industry research experience, including two years experience managing clinical trials or equivalent.
Travel:
Some travel may be required. |
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Salary: to 120K,
Job Type: Permanent,
Total Exp: 4 Yrs,
Start Date: ASAP,
Location: Bedminster, NJ |
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| Job ID: |
PCR-05068-6 - Sr. Clinical Project Manager |
| Description: |
The Project Manager is responsible for:
Strategic planning for the project
Primary liaison with the client and coordination of project team members
Identification and management of the study management team
Delivery of integrated services, project tracking/metrics, project finances and project deliverables
Is the contact liaison and advocate
Identifies, establishes and globally integrates the Study Management Team
Ensures timelines are met
Prepares Gantt charts for management of the project
Reports on study status as frequently as clients request
Proactively tracks budget and scope changes and coordinates vendors
Requirements and Responsibilities:
-Ensure integration of functional service areas.
-Serve as the liaison between Company and clients.
-Ensure adequate project staffing, monitoring and adherence to project budget, and invoicing review.
-Collect, review and maintain regulatory documentation.
-Develop protocol and ensure compliance.
-Develop case report forms.
-Train and supervise project teams.
-Prepare client reports.
-Ensure compliance with project objectives and problem resolution.
-Assist Business Development personnel in defining strategies to increase revenues for assigned client(s).
-Serve as mentor for Project Managers.
-Excellent problem solving skills.
-Excellent interpersonal and communication skills.
Education & Experience:
Candidates for Project Manager must possess a B.S. in biological sciences or related field plus a minimum of 3 years clinical research experience.
Candidates for Program Manager positions must possess an RN or Bachelor's degree in biological sciences or related field with 6 years pharmaceutical industry research experience, including two years experience managing clinical trials or equivalent.
Travel:
Some travel may be required. |
| |
Salary: to 120K,
Job Type: Permanent,
Total Exp: 4 Yrs,
Start Date: ASAP,
Location: Tustin, CA |
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| Job ID: |
RG-11267-6 - Tactical Project Leader - Oncology |
| Description: |
ONCOLOGY TACTICAL PROJECT LEADER ROLE AND RESPONSIBILITIES
Functions as the leader for all studies in Oncology (in charge of driving activities, manages within a matrix organization all study team members)
-Has all operational expertise and effectively represents operational needs to ensure goals are met
-Manages study teams in the Oncology program. Responsible for overall direction of clinical trials activities, including design, planning and
implementation
-Working with Regulatory Affairs, oversees activities in the planning, preparation, coordination and submission of IND packages and in responding to FDA queries, ensure timely preparation of scientifically valid submissions
-Facilitates decision making to ensure milestones are met on time. Maintains decisions once made and ensure all decisions are channeled through him/ her before getting to the team for reality check
-Is the point person for information on status of different projects in program. Provides operational data such as budgeting and resources needs, as well as project status (e.g., monitoring spending/progress) etc.
-Presents and gets approval to budgets
-Gets additional resources for the team
-Assists in preparing scenarios for potential new developments in oncology program. Has the ability to thrive in a balanced environment of commercial imperative, clinical professionalism, scientific rigor and medical ethics
-Manages drug candidate programs from lead clinical candidate selection through clinical development. Provides operational data such as
budgeting, monitoring spending/progress, administration program meetings, etc.
Requirements:
- Needs to be able to manage through a matrix organization
-Thorough working knowledge and significant experience of clinical trial design and development in relevant therapeutic areas (oncology)
-Thorough working knowledge of all aspects of GCP and the regulatory/ethical framework pertaining to clinical trials
-The knowledge, experience and ability to plan, set and manage clinical trial budgets
-Experience in one or more therapeutic areas - Oncology, CNS or Metabolism
-Assists and coaches study team members in CRO negotiations, budget preparation, timelines evaluation, scenarios evaluations with adequate
resources, training to study team members needed
-Together with solid understanding of overall drug development and thorough knowledge of specific areas of drug development. Has the
ability to work within a team in an open, frank and professional manner, building good working relationships with colleagues and peers
-First class communication skills
-Good IT skills in Word, Excel, PowerPoint are essential
Experience:
-10 years of experience in drug development in the biotechnology or pharmaceutical industries, particularly in anticancer drug development
-An advanced science degree (Biomedical, Pharmacy, Chemistry, etc.), MBA or Doctorate and substantial Healthcare industry experiences
-Proven track record as Project Leader ideally with Oncology drug development experience, but other therapeutic areas considered
-Proven record of successful management of multiple projects and be able to demonstrate effective communications and negotiation skills for a wide variety of audiences, including senior management
Relocation Plan Available. |
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Salary: to 150K,
Job Type: Permanent,
Total Exp: 10+ Yrs,
Start Date: ASAP,
Location: Tarrytown, NY |
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