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Senior Clinical Trial Manager at Sarepta Therapeutics in Cambridge, Massachusetts

Posted in Management 30+ days ago.

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.

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