The Clinical Trial Manager (CTM) is responsible for the planning, implementation, and conduct of one region, or less complex, clinical trials in Phase I-IV. The CTM is accountable for the day-to-day operations of multiple clinical trials including but not limited to study start up, conduct and close out activities. The individual will manage the clinical project team members to ensure timely completion of projects; oversee project timeline development and maintenance.
Primary responsibilities include:
Clinical Trial Management
Manage CROs, vendors and consultants that are involved with the clinical trial and program.
Serve as the clinical point person managing protocol execution.
Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
Participate in program strategy meetings, ad hoc clinical operations' initiatives and programs as assigned.
Ensure study staff is appropriately trained on relevant guidelines, regulations and SOP's.
Ensure trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
Assist in preparation of clinical documentation for IND updates as well as NDA submission and other regulatory authority submissions as appropriate.
Review and provide input for reports and clinical documents such as informed consent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities and status updates.
Review and approve clinical monitoring visit reports and ensure that all outstanding follow-up items are closed out in a timely manner.
Responsible for communication and escalation of study related issues as required.
Responsible for forecasting of Investigational Medicinal Product and clinical trial related supplies.
Conduct periodic reviews of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs as well as ensuring all appropriate documents are filed.
Participate and respond to Quality Assurance and/or regulatory authority inspection audits.
Fiscal and Contracts Management
In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents.
Review and approve site budgets, manage clinical trial budgets, provide financial reporting and projections.
Participate in creation of scope of work, budgets, vendor performance and issue resolution.
Reconcile and report vendor and site payments, and change orders ensuring accuracy and timely delivery to finance.
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.
Participate in operational improvement initiatives (e.g. SOP development, training, etc.)
Assist with the development of the clinical components of regulatory submissions including, but not limited to: safety, interim and final study reports.
Education and Skills Requirements:
Bachelor's degree in health sciences or related field.
Minimum of 5+ years' experience in clinical research with at least 2 years' experience in Project Management of complex studies with a focus on pediatric rare diseases preferred.
Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required.
Experience in management of CROs, vendors, and consultants
Experience developing trial plans including site monitoring and risk mitigation strategies, trial budgets, site selection and clinical supply 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.
Therapeutic or medical knowledge preferred.
Strong computer skills including knowledge of Excel, Word, PowerPoint and Outlook.
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 offers a competitive compensation and benefit package
Sarepta is an Equal Opportunity/Affirmative Action employer and participates in e-Verify