Clinical Project Manager

Research & Development Cambridge, Massachusetts


Description

The Clinical Project Manager will be responsible for overseeing the day to day cross-functional activities of an assigned clinical study to ensure deliverables and timelines are met.  This will involve leading a matrix clinical team that includes a mix of internal and external functional experts as well as multiple external vendors.

Responsibilities

  • Develop timelines and key risks for study activities from study start-up through study close out
  • Lead internal clinical team meetings
  • Work with the Program Team Leader to ensure clinical timelines and risks are integrated into the overall project plan
  • Collaborate with other clinical programs and the Head of Clinical Operations to ensure cross team learnings and efficiencies are incorporated across clinical studies
  • Mentor junior clin ops team members, including managing their day to day activities
  • Prepare and lead key external meetings, e.g. dose escalation meetings, safety meetings, etc.
  • Oversee the development of study related materials, e.g. training manuals, study plans, study templates, updates to clinicaltrials.gov, etc.
  • Manage external vendors and serve as the main point of escalation across all functions
  • Review and sign off on monitoring reports
  • Maintain positive site relationships by ensuring PIs are engaged in scientific and strategic developments of the program
  • Collaborate with the Medical Lead to complete ongoing data cleaning, including review of clinical data and patient profiles
  • Work with the sites and Medical Lead to allocate patients into the appropriate cohorts
  • Collaborate with Head of Clinical Operations and Finance to develop an overall study budget and financial forecast
  • Report clinical trial metrics to the Program Team
  • Ensure study is executed in compliance with internal SOPs and GCP guidelines
  • Participate in the development of study synopses, study protocols and protocol amendments, including being the primary author
  • Collaborate in the development of the investigator’s brochure and IND/DSUR annual reports
  • Work closely with supply chain regarding the logistics around the delivery of the drug product

 

Requirements:

  • Bachelor’s degree required
  • 5 (+) five years of Pharma/Sponsor clinical trial management/execution with experience in oncology and/or cell therapy space
  • Excellent verbal and written communication skills
  • Strong regulatory knowledge, including Good Clinical Practices (GCPs)
  • Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability