Clinical Trial Project Manager (CONRAD)

Location
Arlington, Virginia
Posted
Jun 29, 2017
Closes
Aug 03, 2017
Ref
2881601
Function
Other
Hours
Full Time

The Clinical Project Manager is responsible for the execution of assigned clinical trials from protocol design to the final study report. The position is responsible for coordinating all efforts of trial implementation both within CONRAD and through a wide variety of collaborators and vendors. **This position is located in our Northern Virginia Office in Arlington, VA**

  • Manages project teams to deliver high quality clinical trial(s)

  • Drives all aspects of the project management process from planning, execution, control and closure.

  • Manages all aspects proactively.

  • Works with functional areas on planning, initiating, executing, closing and resourcing for clinical trials (e.g., product development, data management and stats, regulatory)

  • Assists in preparation of study design and responsible for writing of protocols

  • Estimates project budgets, develops enrollment projections, and drug supply needs

  • Responsible for creating and maintaining timelines for each project, and uses timelines to track and manage a project’s progress

  • Negotiates budgets and contracts with clinical sites and central laboratories

  • Directs development of model informed consent forms

  • Directs development of CRF forms

  • Reviews study-related support materials (e.g., study manual, monitoring plan, and edit checks)

  • Reviews trial conduct and quality at all levels (e.g., monitoring, data management)

  • Responsible for periodic study team meetings

  • Responsible for overseeing monitoring and evaluation of project milestones

  • Reviews study metrics for performance and quality with the team and management

  • Ensures review of Clinical Trial Master File for completeness

  • Oversees preparation of clinical study reports and manuscript(s)

  • Ensures collaborators provide deliverables (e.g., query generation resolution, data base lock, and statistical report, results of laboratory analyses).

  • Informs these groups of timelines.

  • Position has overall responsibility for ensuring study conduct is completed in timely manner and in compliance with all regulations and SOPs

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