Senior Clinical Operations Lead

Sarepta Therapeutics•Cambridge, MA

5d•Onsite

About The Position

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.

Requirements

Experience in management of CROs, vendors and consultants
Documented training, knowledge, and application of current FDA/EU Regulations, GCP and ICH guidelines for patient registries and studies
Experience developing trial plans including site management, risk mitigation strategies, trial budgets and program-level budgets
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
Bachelor’s degree in health sciences or related field
Minimum of 7+ years’ experience in clinical research with at least 4 years’ experience in study management with strong experience with study phases I-IV, global trials, and with complex trial designs.
Candidates must be authorized to work in the U.S.

Nice To Haves

Rare disease study management is recommended.

Responsibilities

Oversees Clinical Research Organizations (CROs), vendors and consultants involved with the clinical 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 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
Responsible for communication and escalation of study related issues to the COPL
Provides enrollment forecasting to internal stakeholder, such as Clinical Supply, at agreed upon frequency
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
Leads 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.)