Clinical Trial Manager
Proclinical is currently recruiting for a Clinical Trial Manager with a leading biotechnology company located in Boston, MA. As the Clinical Trial Manager, you will be responsible for all operational management of clinical trials.
- Selection and management of CRO, vendors and consultants that are involved with the clinical trial.
- Oversee vendor(s) to ensure compliance with contract specifications (including budget), SOPs and the study Oversight Plan, including review of CRO progress reports and metrics.
- Coordinate financial and legal documentation exchange between sponsor, vendors and sites.
- Establish/maintain study milestones and ensure accurate tracking and reporting of study metrics and timelines.
- Organize and facilitate/document study cross-functional team meetings.
- Serve as point person for trial execution internally & externally.
- Coordinate and participate in data reviews in conjunction with Data Management staff.
- Review study Trial Master File periodically for quality control measures.
- Review and provide input for clinical study documents such as informed consent, protocols, Investigator's Brochure, recruitment materials, yearly updates to the regulatory authorities and status updates.
- Review and approve study related plans generated by CRO and study vendors.
- Responsible for oversight of identification and selection of investigator sites.
- Responsible for communication and escalation of study related risks and issues as required.
- Ensure study staff is appropriately trained on relevant guidelines, regulations, and SOPs.
- Assist in the oversight of monitoring activities and site visits.
- May represent Clinical Operations in cross-functional initiatives.
- Participate in review and revision of departmental SOPs, provide support to establish and maintain operational infrastructure.
- Manage and attend Investigator Meetings, conferences, and perform co-monitoring as needed.
If you are having difficulty in applying or if you have any questions, please contact Miles Tobin at (+1) 617-545-5922 or firstname.lastname@example.org.
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.