Clinical Operations Lead job in Cambridge, USA

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First Name*

Last Name*

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Job type: Permanent

Discipline: Clinical Trial Assistant (CTA), Clinical Research Associate (CRA), Project/Study Manager (CSM/CPM)

Location: United States

This vacancy has now expired. Please see similar roles below...

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.

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