The Importance of the Role

The Senior Clinical Operations Lead, Clinical Operations manages all aspects of assigned clinical trials as well as the study project plan, including timeline, budget, and vendors and is expected to conduct large studies of high complexity. The Sr. COL will provide leadership and potentially line management within Clinical Operations and guidance with regards to operational deliverables

The Opportunity to Make a Difference

• Oversees Clinical Research Organizations (CROs), vendors and consultants involved with theclinical trials
• Serves as the point of contact for protocol execution and leads the Clinical Trial Team (CTT)
• Mentors junior team members and ensures alignment with any supporting Clinical Operations
Leads (COLs) assigned to studies
• Establishes study timelines in line with company goals and ensures accurate tracking andreporting of study metrics and progress through completion of study dashboards
• Works cross-functionally to ensure clinical program timelines and goals are met and risks areappropriately escalated to the Clinical Operations Program Lead (COPL)
• Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
• Develops, reviews and/or consults on reports and clinical trial documents such as informedconsent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities andstatus updates
• Responsible for communication and escalation of study related issues to the COPL
• Provides enrollment forecasting to internal stakeholder, such as Clinical Supply, at agreed uponfrequency
• Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance withICH/GCP and company SOPs as well as ensuring all appropriate documents are filed
• Participates and responds to Quality Assurance and/or regulatory authority inspection audits
• In conjunction with CRO and appropriate internal stakeholders, facilitates the development oftrial budgets and execution of clinical trial agreements and other relevant documents
• Manages the clinical trial budget and provides financial reporting and projections to Finance
• Leads creation of scope of work and budgets and escalates vendor performance issues to COPLand Procurement as necessary
• Participates in operational improvement initiatives (e.g., SOP development, training, etc.)

More about You

Desired Education and Skills:
• Experience in management of CROs, vendors and consultants
• Documented training, knowledge, and application of current FDA/EU Regulations, GCP and ICHguidelines for patient registries and studies
• Experience developing trial plans including site management, risk mitigation strategies, trialbudgets and program-level budgets
• Proficient written and verbal communication skills
• Ability to collaborate effectively with the study team, cross-functional team members andexternal 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
• Bachelors degree in health sciences or related field
• Minimum of 7+ years experience in clinical research with at least 4 years experience in studymanagement with strong experience with study phases I-IV, global trials, and with complex trialdesigns. Rare disease study management is recommended.

What Now?

Were always looking for solution-oriented, critical thinkers.

So, if youre comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.

#LI-Onsite

This position requires work on site at one of Sareptas facilities in the United States.

The targeted salary range for this position is $152,400 - $190,500 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sareptas compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

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

Sarepta Therapeutics offers a competitive compensation and benefit package.