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.