Clinical Project Manager

  • location: Cambridge, MA
  • type: Contract
  • salary: $85 - $95 per hour
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job description

Clinical Project Manager

job summary:
Start up biotech looking for an experienced project manager to help drive various small studies in a dynamic cutting edge organization

With the support of CRAs under the direction of Clinical Director you will lead oncology based studies with a cell therapy focus do help progress an early Phase 1 drug through the entire process.

 
location: Cambridge, Massachusetts
job type: Contract
salary: $85 - 95 per hour
work hours: 9 to 5
education: Bachelors
 
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
 
qualifications:
  • Bachelor's
  • 7+ years experience
  • 2-3 years Oncology necessary
  • Cell Therapy a plus
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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