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.
Key Responsibilities
Study Leadership and Execution
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
CRO and Vendor Oversight
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 escalate issues proactively
Site Management and Enrollment
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
Quality, Data, and Inspection Readiness
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
Cross Functional Collaboration
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
Required Qualifications
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
Preferred Qualifications
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, ACR20/50/70, DAS28, EASI, PASI) and centralized endpoint adjudication
Experience with risk based monitoring and decentralized trial elements
Proficiency with CTMS, eTMF, EDC, and IRT systems

Work arrangement
Yes