Clinical Operations Lead

Proclinical is currently recruiting for a Clinical Operations Lead with a biotechnology company located in Cambridge, MA.

Job Responsibilities:

• 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.

#LI-ZH1