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
- 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
- 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.