Clinical Operations Lead
Proclinical is currently recruiting for a Clinical Operations Lead with a biotechnology company located in Cambridge, MA.
- Lead SMT meetings and cross-functional coordination and alignment
- Ensure all study forms and materials are developed according to the governing SOPs
- Align with the SMT the team goals, deliverables, timelines and ensure these are on track or met
- Vendor management and oversight (including CRO): selection, contracting, raising PO, tracking budget, performance/metrics/KPIs and attend vendor meetings
- Support CRO with site contract execution- liaise with legal team when required and perform site budget oversight
- Full study budget tracking and forecast projecting. Liaise and report back to the Finance Business partner
- Oversee the study filing systems (ie: sharepoint, trial master file) and ensure proper filing performing Quality checks as needed
- Support with Study Approval governance and system. Ensure study data is accurate and updated on an ongoing basis in the system
- Oversee the trial coordinator associate assigned to the studies for administrative support (ie: scheduling meetings, taking minutes)
- Serves as liaison between and coordinate SMT (including Affiliates and field MSLs) and sites and/or any Third-party vendors
- Performs risk management and identifies and proactively raises issues to the SMT as appropriate, prior to their becoming critical. Maintains corresponding study logs
Skills and Requirements:
- Master of Science Degree in Pharmacology, Immunology or other Biomedical Sciences or PharmD or international equivalent
- 10 years' Experience in Pharma Industry or CRO or 5 years in a similar role (e.g.: Study Lead, Clinical Operations lead, Clinical Project Manager, Clinical Trial Head)
- Robust Clinical Operations/ Medical Research operations background
- Experience with Medical Affairs and Observational studies
- Experience in Neurology/ Immunology therapeutic areas
- Global experience (including US and EU investigators/ sites)
If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.