Senior Clinical Operations Lead

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.

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 and reporting of study metrics and progress through completion of study dashboards.

Works cross-functionally to ensure clinical program timelines and goals are met and risks are appropriately 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 informed consent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities and status updates.

Communicates and escalates study related issues to the COPL.

Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance with ICH/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 of trial budgets and execution of clinical trial agreements and other relevant documents.

Manages the clinical trial budget and provides financial reporting and projections to Finance.

Led creation of scope of work and budgets and escalates vendor performance issues to COPL and Procurement as necessary.

Participates in operational improvement initiatives (e.g., SOP development, training, etc.).

What Now?

We’re always looking for solution-oriented, critical thinkers. So, if you’re 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.

This position requires work on site at one of Sarepta’s facilities in the United States.

The targeted salary range for this position is $152,400 - $190,500 per year.