Clinical Trial Manager
Proclinical is currently recruiting for a Clinical Trial Manager with a pharmaceutical company located in Boston, MA.
- Customize/update any study-specific plans and process flows for multiple clinical vendors, as appropriate e.g., TMF Plan, site training plan, site monitoring plan, cross functional data review plan, IP release plan etc.
- Ensure quality of the trial master file through content (QC) review of document packages submitted for entry into the TMF and liaise with project teams to resolve any issues identified with the documents submitted.
- Assist CPL by tracking compliance to all study level plans and escalating any variances.
- Serve as system expert and point of contact for business technologies used during the study (e.g., EDC, Investigator Portal, TMF).
- Ensure CRA compliance with the study parameters via review of monitoring visit reports
Skills and Requirements:
- >3 years of clinical research experience, in the pharmaceutical industry with a solid understanding of technology and processes used in drug development.
- Oncology or rare disease experience.
- Work with CROs and vendors to drive timelines and deliverables.
- Experience working with study budgets and forecasting; contract and invoice review.
If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.
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.