Clinical Operations Lead

Company: Sarepta Therapeutics
Location: Cambridge
Posted on: May 26, 2023

Job Description:

The Position:

The Clinical Operations Lead, Global Clinical Operations manages all aspects of assigned clinical trials as
well as the study project plan, including timeline, budget, and vendors. The COL may take responsibility
for smaller, less complex studies or serve in a supporting role on larger, more complex studies.

Primary Responsibilities Include:

• Oversees CROs, vendors and consultants involved with the clinical trials
• Serves as the point of contact for protocol execution
• Leads the Clinical Trial Team (CTT) for smaller, less complex studies or may support a Sr. COL on larger, more complex 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 CPL and Procurement as necessary
• May participate in operational improvement initiatives (e.g., SOP development, training, etc.) Desired Education and Skills:
  • Documented training, knowledge, and application of current FDA Regulations, GCP and ICH guidelines in clinical trials
  • Familiarity with 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
  • Bachelor's degree in health sciences or related field
  • Minimum of 3-5 years' experience in clinical research with at least 1-2 years' experience in study management preferred
    
    #LI-Hybrid
    
    This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.
    
    The targeted salary range for this position is $120,000 - $150,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's 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.
    
    Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

Keywords: Sarepta Therapeutics, Cambridge , Clinical Operations Lead, Accounting, Auditing , Cambridge, Massachusetts