Senior Clinical Trial Manager at Sarepta Therapeutics in Cambridge, Massachusetts

Job Description:

The Sr. Clinical Trial Manager (CTM) is responsible for the planning, implementation and conduct of large, global, complex clinical trials in Phase I-IV; or multiple smaller early-phase studies. Additionally, the Sr. CTM is expected to provide leadership within the department and guidance with regards to the operational aspects of executing clinical development deliverables.

Primary Responsibilities Include:

Clinical Trial Management

• Serve as the clinical point person managing protocol execution, including the oversight of CROs, vendors and consultants that are involved with the clinical trial and program.


• Responsible for oversight and project management of individual studies as well as relevant program related activities.


• Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.


• Ensure trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs.


• Participate in program strategy meetings, ad hoc clinical operations' initiatives and programs.


• Assist in preparation and review of clinical documentation such as informed consent, clinical protocols, Investigator Brochure, Clinical Monitoring Plan, Project Plan.


• Assist with the development of the clinical components of regulatory submissions including, but not limited to safety, interim and final study reports.


• Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews.


• Participate and respond to Quality Assurance and/or regulatory authority inspection audits.

Fiscal and Contracts Management

• Participate in request and review of scope of work, budgets, vendor performance and issue resolution.


• In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents.


• Manage clinical trial budgets, providing ongoing financial reporting and projections to finance group.


• Responsible for creation and management of program-level budget(s) with Program Lead.

Cross Functional Mentoring and Leadership

• Work cross-functionally to ensure clinical program timelines and goals are met.


• Provide study-specific mentoring and line management for junior team members, as appropriate.


• Assume leadership role in operational improvement initiatives (e.g. SOP development, training etc).

Education and Skills Requirements:

• Bachelor's degree in health sciences or related field.


• Minimum of 8+ years' experience in clinical research with at least 5 years' experience in study management.


• 1-3+ years of clinical study management experience with global clinical studies.


• Experience in management of CROs, vendors and consultants.


• Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials.


• Experience developing trial plans including site monitoring, risk mitigation strategies, trial budgets and program-level budgets, site selection and clinical supplies management.


• Proficient written and verbal communication skills.


• Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.


• Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project.


• Position may require some travel.


• Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.