What are the responsibilities and job description for the Sr. Clinical Trial Manager position at Viltis?
Job Title: Sr. Clinical Trial Manager
Location: San Diego, CA (On-site, Full-Time)
Our client is a clinical-stage biopharmaceutical company focused on developing first-in-class or best-in-class therapies targeting metabolic and endocrine disorders. With an exciting and diverse pipeline—including VK2735 (a dual GLP-1/GIP agonist for metabolic disorders), VK2809 (a thyroid hormone receptor-β agonist targeting NASH and lipid disorders), and VK0214 (for X-ALD)—Viking is committed to advancing novel treatments that improve patients’ lives.
Viltis is seeking a Sr. Clinical Trial Manager on behalf of our client to lead and manage the operational execution of key clinical programs from start-up through closeout. This is a full-time, on-site position in San Diego where you’ll work closely with internal teams, CROs, and vendors to deliver high-quality, timely, and compliant clinical trials.
- Lead the operational aspects of assigned clinical trials (Phase 1–2 and beyond), including timelines, budgets, vendor oversight, and site management.
- Serve as the primary liaison between internal stakeholders, CROs, vendors, and study sites.
- Proactively identify, escalate, and resolve operational risks or barriers to ensure trial success.
- Support protocol development, site feasibility, ICF review, and essential trial documentation.
- Monitor trial progress using KPIs; ensure compliance with protocol, GCP/ICH, and regulatory standards.
- Oversee contracts and budget management in collaboration with finance and legal teams.
- Maintain audit-ready Trial Master File (TMF/eTMF) documentation.
- Coordinate and lead investigator meetings, monitoring visits, and cross-functional study team meetings.
- Bachelor’s degree in a scientific or health-related discipline; advanced degree or certification a plus.
- 5 years of clinical trial operations experience within pharma, biotech, or CRO (Phase 1–2 strongly preferred).
- Demonstrated vendor/CRO oversight experience and proven ability to manage multiple clinical sites.
- Strong understanding of GCP/ICH guidelines and global clinical regulatory requirements.
- Excellent organizational, analytical, and communication skills with a solutions-oriented approach.
- Proficiency with CTMS, eTMF, EDC systems, and Microsoft Office tools.