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.

Job Responsibilities:

• 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 m.tobin@proclinical.com.

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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