Clinical Project Manager

  • Worcester, MA

Employment Type

: Full-Time

Industry

: Scientific Research



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Clinical Project Manager

Degree:
- BA/BS with scientific major preferred

Experience:
- 5+ yrs. clinical trial project management exp. in a pharma, biotech or relevant CRO

\"MUST HAVES\":
- Strong study management track record; showing clear proficiency in clinical project management skills
- Thorough understanding of GCP guidelines & Federal and International regulations.
- Good understanding of cross-functional clinical processes including clinical monitoring, data management, biostats, medical writing, drug safety and regulatory affairs
- Solid Vendor management skills
- Exp. utilizing a variety of software programs (Microsoft Office products and Clinical database software)

Duties/Responsibilities:
-?Execute trial operational plans while ensuring compliance to SOPs, Federal and international regulations and GCP
-?Manage all aspects of clinical trial operations, including vendor performance, internal metrics, quality assurance checks and communication of trial status within and outside the trial team
-?Develop outsourcing specifications for vendor requests for proposals and participate in and guide study team in vendor selection and management
- Responsible for independently managing multiple clinical trials of moderate complexity or managing a broader range of activities on large multi-center studies
-?Specific responsibilities include the clinical trial management of timelines, budgets, resources, investigational sites, CROs, ancillary vendors along with key project deliverables in compliance with SOPs, Federal and international regulations and GCP guidelines.
-?Prepare and update key project documentation (progress reports, timelines, and meeting minutes) ensure adverse events are reported according to regulatory requirements and provide updates to management
-?Manage vendor to Scope of Work (SOW), quality, and budget.? Review and approve all vendor invoices and manage accruals and SOW changes
-?Work with CRO and or core team members to address issues and risks associated with achieving the deliverables and develop risk mitigation plans

Location: Worcester, MA area
Start Date: ASAP!!
Duration: 6+ Month Contract(runs through atleast the end of 2019)
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Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task


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