Clinical Planning Manager- III/IV Job in Jersey City, New Jersey US
Clinical Planning Manager- III/IV
Department: Global Clinical Operations
I. POSITION SUMMARY:
The Clinical Planning Manager is responsible for supporting the Clinical Trial/Project Teams by strategically developing and sustaining study timelines, providing evaluations of potential risks and conflicts, supporting the team on proactively resolving potential deviations and presenting clear timeline reports. This position will be in a team orientated environment that is empowered to drive the studies with minimal deviations, accelerating timelines and providing metrics to implement future enhancements.
II. PRIMARY JOB RESPONSIBILITIES:
The Clinical Planning Manager will work strategically and collaboratively with all Clinical Teams, Corporate Project Management, Purchasing and CROs.
Reports directly to the Senior Director-Global Clinical Trial Critical Path Management.
1. Strategically develop and sustain high quality, realistic, cross functional clinical trial plans from study concept through completed clinical study reports. The Clinical Planning Manager will develop the study timeline when the synopsis/draft protocol is available.
2. Partner with Corporate Project Management and Regulatory to implement project strategies and improve efficiency by identifying and implementing new business processes.
3. Develop and sustain the ROW timelines to meet all company and CRO deliverables.
4. Responsible to partner with the Clinical Development lead, Global Operations department and the study team to ensure timely delivery of all clinical milestones. The Clinical Planning Manager will be expected to identify gaps and risks in the study plans and work with the team and Management to proactively develop solutions which will increase efficiency and minimize timelines.
5. Define baselines and provide metrics to identify areas and trends that can be used by the clinical teams for future enhancements.
6. Responsible for arranging and leading discussions on the clinical study plans.
7. Present clear clinical study plan reports to many stakeholders
8. Partner with study team leaders to tactically drive critical path elements within the study.
9. Work collaboratively with Global Recruitment Operations, Global Site Start Up Operations and CRO Oversight to advantageously reduce timelines for study start up activities.
10. Operate within the STAR initiative (communication and accountability model).
III. ADDITIONAL JOB RESPONSIBILITIES:
11. Provide continuous improvement on the individual study plan and MS Project template.
12. Develop department portfolio based schedules and resource planning methodologies.
13. Identify state of the art planning tools to minimize deviations from established timelines.
IV. POSITION QUALIFICATIONS:
Life science and/or business degree with at least 5-10 years experience in clinical research. MS and PMP certification desirable.
Strong knowledge and experience of the clinical study process.
At least 3-5 years of Project Management experience required.
Excellent written, communication and organizational skills.
Strong MS Project experience required.
Ability to multi-task and perform under demanding and aggressive timelines while remaining focused on the study goals.
Proven ability to interact with different functional groups.
