Senior Clinical Trial Manager (CTM)

Location: This position may be performed remotely with travel to the Boston area as needed.

Position Summary

This role will be responsible for project management in the initiation, execution and close out of domestic and international clinical studies, including study concept and design, feasibility assessments, study start-up, contract and budget oversight, data exchange and support of data analysis and interpretation.

This position requires both the knowledge and experience to work within established clinical trial paradigms while exploring and embracing new approaches to conducting research to support data aggregation and analysis to advance patient care. The Sr. CTM will participate on clinical project teams to achieve quality results in a cost-effective and timely manner. S/he will be a key team member to establish key practices and procedures for the clinical team.

Primary Responsibilities

• Manage study activities in the successful execution of clinical trials from protocol concept to clinical study report, complying with Good Clinical Practice (GCP) guidelines and international regulations
• Manage strategic engagement with key collaborators
• Set-up and oversee clinical trial-related trackers such as regulatory documents, trial master file (TMF), startup progress, screening/enrollment, study invoices/payments, project budgets, etc.
• Key contributor to IRB/EC and regulatory submissions
• Oversee TMF reviews to ensure completeness and inspection readiness
• Regularly review documents to ensure adherence to Clinical Operations and/or project specific quality requirements (e.g. SOPs, work practices, training guides)
• Identify and mitigate against study risks, escalating as necessary
• Direct initiatives to identify and implement best practices and continuous improvement plans in clinical development

Education and Professional Experience

• Bachelor's degree in a scientific field required; advanced scientific degree a plus
• 5+ years directly managing clinical trials in Sponsor or CRO setting
• In-depth knowledge of clinical trial operations, ICH, GCP Guidelines and other applicable regulatory requirements
• Experience directing members of clinical operations teams
• Experience working in a team across multiple functional areas (e.g., Quality Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance)

Other Essentials and Key Success Factors

• Intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
• Ability to think critically in fast-paced projects with a keen sense of urgency and demonstrated ability to problem solve
• Self-motivated and able to work autonomously, as well as a member of a collaborative team
• Highly-organized and detail-oriented with a passion to deliver quality results
• Strong verbal and written communication skills with an ability to build relationships internally and externally
• Highest levels of professionalism, confidence, personal values and ethical standards