Clinical Operation Lead

Highghly Competitive Salary
  1. Permanent
  2. Clinical Trial Assistant (CTA), CRA Manager
  3. United States
Cambridge, USA
Posting date: 09 Oct 2020

Proclinical is currently recruiting for a REMOTE Clinical Operation Lead with a biotechnology company.

Job Responsibilities:

  • Lead Study Management Team (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 when required and perform site budget oversight.
  • Full study budget tracking and forecast projecting. Liaise and report back to 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:

  • Familiar with Sharepoint, CTMS, MS project (Planview/Plansource), RAVE EDC, ePROs, eTMF.

If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.

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.