Clinical Operations Director

8 hours ago

South San Francisco, California, United States Remegen Biosciences, Inc. Full time
Job Title: Clinical Operations Director

Remegen Biosciences, Inc. is seeking a highly skilled Clinical Operations Director to join our team. As a key member of our clinical operations team, you will be responsible for managing clinical trials from start to finish, ensuring compliance with regulatory requirements and delivering high-quality results.

Key Responsibilities:
  • Manage global clinical trial execution, ensuring compliance with ICH/GCP, SOP, regulatory, global and local guidelines.
  • Participate in CRO selection and negotiation of master service agreements, scope of work contracts, change orders, etc.
  • Proactively manage trial start-up activities, including feasibility, country/site selection, site contract and budget negotiation, database and lab setup, study plans, training requirements, etc.
  • Collaborate with cross-functional teams and external vendors to identify clinical trial operational risks and develop mitigation strategies to ensure quality delivery of the clinical trial to support regulatory submissions.
  • Manage CRO and other external partners, collaborating with internal cross-functional teams to ensure operational delivery of assigned clinical trials.
  • Plan and implement quality checks for multiple clinical trials, establishing and reviewing key performance indicators, metrics, and progress reports, identifying barriers to timely and successful trial execution.
  • Provide clinical operational input to protocol, ICF, safety, and other relevant clinical trial key documents and plans.
  • Drive and support the development of work instructions and SOPs, contributing to Clinical Operations functional initiatives for role clarity and institution of best practices.
  • Support the manager to lead clinical operation activities, including feasibility, country selection, regulatory and ethic submissions, site startup, operational input to study design, risk-based quality management.
  • Prepare clinical trial documents, such as project plans, communication plans, clinical trial management plan, site selection, SIV, patient recruitment and retention plan, etc.
  • Effectively communicate regular clinical trial updates to management on clinical trial progress, performance, risks, and mitigation strategies.
Requirements:
  • Bachelor of Science or equivalent degree, required.
  • Master of Science/Advanced degree preferred.
Benefits:
  • 401(k) and matching program
  • Medical, Vision, and Dental Insurance
  • Flexible Spending Account
  • Short- and long-term disability
  • Life insurance
  • Employee Assistance Program
  • Employee discounts
  • Paid time off/vacation/sick time
  • Professional development assistance
  • Referral program

Remegen Biosciences, Inc. is an Equal Opportunity Employer. We adhere to and promote equal employment opportunity (EEO) for all. Must be able to work legally in the United States without sponsorship from employer.

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