Senior Clinical Trial Manager

Our client is a Small/Mid Sized Biotech in the SF Bay Area. Currently advancing large molecule therapeutics for Oncology and Autoimmune diseases.

• Lead the operational planning and execution of Phase 1 through Phase 3 clinical trials in autoimmune and inflammatory indications, ensuring delivery on time, within budget, and in compliance with ICH GCP, FDA, and applicable global regulations
• Serve as the primary operational point of contact for assigned studies, driving study timelines, milestones, and deliverables
• Develop and maintain study plans including monitoring, communication, recruitment and retention, and risk management plans
• Contribute to protocol development, informed consent forms, CRF design, and other key study documents

• Select, manage, and hold accountable CROs and specialty vendors (central and specialty labs, IRT, eCOA, imaging, biomarker labs)
• Review and track vendor scopes of work, budgets, invoices, and change orders
• Conduct regular performance reviews against KPIs and elevate issues proactively

• Partner with sites and key opinion leaders in rheumatology, dermatology, gastroenterology, or nephrology to drive startup, activation, and enrollment
• Develop creative recruitment strategies for autoimmune populations, including patients on background immunosuppressive or biologic therapies
• Oversee site monitoring activities, review monitoring visit reports, and ensure timely resolution of issues and protocol deviations

• Maintain inspection readiness through oversight of the TMF / eTMF
• Partner with Data Management, Biostatistics, Clinical Science, Safety, and Regulatory on data review, query resolution, and database lock
• Support audits and regulatory inspections, and drive CAPA plans as needed

• Lead or co lead the Study Execution Team and present study status to leadership
• Support clinical study reports, regulatory submissions, and investigator meetings
• (Senior CTM) Mentor and guide CTMs, CTAs, and Clinical Research Associates; may oversee multiple studies or a program

• Bachelor's degree in life sciences, nursing, or a related field
• 5 to 7 years of clinical operations experience in the biotech or pharmaceutical industry, including at least 3 years managing clinical trials as a CTM or equivalent
• Direct, hands on experience managing clinical trials in autoimmune or inflammatory disease (for example lupus / SLE, lupus nephritis, rheumatoid arthritis, Sjögren's, myasthenia gravis, IgA nephropathy, atopic dermatitis, psoriasis, or IBD)
• Sponsor side (in house) experience, with demonstrated CRO and vendor oversight
• Experience across the full study lifecycle, from startup and site activation through closeout and database lock
• Strong working knowledge of ICH GCP, FDA regulations, and global clinical trial requirements
• Proven ability to manage study budgets, timelines, and vendor contracts
• Excellent communication, organization, and problem solving skills, with the ability to influence without authority

• Advanced degree (MS, PharmD, PhD, RN, or similar)
• Experience with biologics, or novel immunology modalities
• Global trial experience across North America, Europe, and/or APAC
• Experience supporting IND, NDA, or BLA submissions and regulatory inspections
• Prior experience at a small to mid sized biotech building processes in a growing clinical operations function
• Familiarity with autoimmune specific endpoints and assessments (for example SLEDAI, BICLA, ACR
  20/50/70, DAS
  28, EASI, PASI) and centralized endpoint adjudication
• Experience with risk based monitoring and decentralized trial elements
• Proficiency with CTMS, eTMF, EDC, and IRT systems