Cliniical Project Manager

About the Company:

 

Global Research Services is a global, international full service clinical research organization headquartered in Rockville, MD.  We are a leader in the global management of cardiovascular, renal, stroke, metabolic, and pulmonary clinical development programs for the pharmaceutical, biotech, and medical device industries.

 

We provide a full range of clinical trial management services that include protocol design, project management, data management, clinical site monitoring, biostatistical analysis, report writing, regulatory support, and drug/device development consulting.

 

Clinical Project Manager

 

As the Clinical Project Manager (PM) you will be responsible for leading the project team in development strategy design process and execution for a clinical trial, optimizing metrics including risk, cost, quality, and time tradeoffs consistent with our sponsor’s objectives. You will monitors the project development process and ensures that key requirements and milestones are identified and met. You will be the point-of-contact for cross-functional communication and tracking.  This is an opportunity to join a global leader in clinical research and work with a talented team of experienced individuals.

 

 

Responsibilities:

 

· Participates in all aspects of the project from the proposal process, bid defense, start up through study closure.

· 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.

· Collaborates with sponsors to ensure that all relevant scientific issues and opportunities are addressed in project plan.

· Develops and monitors study budgets and timelines. Partners with functional peers to manage, adjust, and revise project timelines/budgets as necessary.

· Mentors and guides the project team to deliver high quality work within the agreed upon timelines as discussed with the Sponsor..

· Manages resource constraints, risks, and conflicts

· Manages cross functional groups to ensure effective communication, and on-time, on-budget completion of contracted tasks.

· Documents project team’s 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.

 Education and Experience:

 

·  Bachelors Degree in a life sciences or related field (advanced degree desirable)and 2 or more years of project management experience and 5 or more years of clinical research experience in either a CRO or pharmaceutical company with experience in Phase II-IV..

·  Thorough knowledge of clinical research discipline, FDA regulations, and requirements governing the conduct of clinical trials including GCP and ICH.

·  Ability to budget and forecast preparation for clinical studies

·  Strong leadership skills with a positive attitude

·  Ability to work successfully in a team environment requiring matrix management.

·  Ability to evaluate and critique scientific reports and literature relative to drug and device development.

·  Effective oral/presentation and written communication skills . 

·  Excellent organizational and negotiation skills.

·  Experience with team building and conflict resolution.

 

Please submit your resume to globaljobs@grs-cro.com reference GRS-PM