Randstad Clinical Operations in Jersey City, New Jersey
Jersey City, NJ
Tuesday, October 4, 2016
Randstad Life Sciences
Job Title: Clinical and CMC Planning Manager
- The Manager, Clinical and CMC Planning is responsible for supporting Clinical Trial/Project Teams by strategically developing and maintaining clinical study and/or Pharmaceutical Science timelines, providing evaluations of potential risks and conflicts, supporting the team on proactively resolving potential deviations, and presenting clear timeline reports. This person will work in a team orientated environment and is empowered to drive clinical studies and/or Pharmaceutical Science activities with minimal deviations, accelerating timelines and providing metrics to implement future enhancements.
Develop and maintain high quality, realistic, cross functional clinical trial plans from study concept through completed clinical study reports. The Manager, Clinical and CMC Planning will develop the study timeline when the synopsis/draft protocol is available.
Support Pharmaceutical Science teams by developing and maintaining high quality, realistic Chemistry, Manufacturing & Control (CMC) plans for products in development.
Partner with Project Management and Regulatory Affairs to implement project strategies and improve efficiency by identifying and implementing new business processes.
Develop and maintain NA/ROW clinical study timelines to meet all company and CRO deliverables.
Partner with the Clinical Development lead, Global Operations department and the study team to ensure timely delivery of all clinical study milestones. The Manager, Clinical and CMC Planning 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.
Partner with Pharmaceutical Sciences Strategy to ensure timely delivery of all CMC milestones. The Manager, Clinical and CMC Planning will be expected to identify gaps and risks in the CMC plans and work with the team and Management to proactively develop solutions which will increase efficiency and minimize timelines.
Define baselines and provide metrics to identify areas and trends that can be used by the teams for future enhancements.
Responsible for arranging and leading discussions on the clinical study and CMC plans.
Present clear clinical study and CMC plan reports to stakeholders within the company.
Partner with study team leaders to tactically drive critical path elements within the study.
Work collaboratively with Global Recruitment Operations, Global Site Start Up Operations and CRO Oversight to advantageously reduce timelines for study start up activities.
Operate within the Actavis Governance Board model for communication and accountability.
Provide continuous improvement on individual clinical study and CMC plans and standard Planisware templates.
Assist in developing the department portfolio based schedules and resource planning methodologies.
Identify state of the art planning tools to minimize deviations from established timelines.
Life science and/or business degree with at least 5-10 years of experience. MS degree and PMP certification desirable.
Strong knowledge of and experience with clinical study and/or Pharmaceutical Science processes.
At least 3-5 years of Project Management experience required.
Excellent written, communication and organizational skills.
Strong MS Project and/or Planisware 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.
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Life and AD&D Insurance