The Clinical Trial Manager II (CTM II) is responsible for the planning, implementation, and conduct of regional 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.
- Serve as the clinical point person managing protocol execution, including the oversight of CROs, vendors and consultants that are involved with the clinical trial
- Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
- Ensure study team adherence to ICH/GCP/Federal and local regulations and company specific SOPs.
- Responsible for ongoing study communication and escalation of study-related issues as required.
- 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.
- Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews.
- Assist with the development of the clinical components of regulatory submissions including, but not limited to safety, interim and final study reports.
- Participate and respond to Quality Assurance and/or regulatory authority inspection audits.
- 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.
- 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.).
- Perform other related duties as required.
Education and Skills Requirements:
- Bachelor's degree in health sciences or related field.
- Minimum of 7+ years' experience in clinical research with at least 2 years' experience in study management.
- 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, 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.
- Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project.
- Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion
- Position may require some travel.
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.