Senior Clinical Trial Manager

Precision Point; San Francisco (CA); On-site; USD 180,000 - 210,000; Full time

Job summary

Precision Point, a SF Bay Area biotech, seeks a Study Operations Leader to drive Phase 1–3 trials in autoimmune and inflammatory diseases. You will manage timelines, budgets, and regulatory compliance to ensure on-time deliveries across complex programs.

Responsibilities include CRO/vendor oversight, site activation and enrollment, TMF/eTMF readiness, and cross-functional collaboration. Mentorship of CTMs and the broader clinical operations team is expected.

Qualifications

• Bachelor's degree in life sciences, nursing, or a related field.
• 5–7 years clinical operations experience in 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.
• 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.

Responsibilities

• Lead the operational planning and execution of Phase 1 through Phase 3 trials in autoimmune/inflammatory indications.
• Serve as primary operational contact for assigned studies, driving timelines and deliverables.
• Develop and maintain study plans including monitoring, recruitment, retention, and risk management.
• Contribute to protocol development, informed consent forms, CRF design, and other key documents.
• Select, manage, and hold CROs and specialty vendors accountable.
• Review vendor scopes of work, budgets, invoices, and change orders.
• Conduct regular performance reviews against KPIs and elevate issues proactively.
• Partner with sites and KOLs to drive startup, activation, and enrollment.
• Develop creative recruitment strategies for autoimmune populations.
• Oversee site monitoring activities and ensure timely issue resolution.
• Maintain inspection readiness through oversight of TMF/eTMF.
• Collaborate on data review, query resolution, and database lock.
• Support audits and regulatory inspections, and drive CAPA plans.
• Lead or co-lead the Study Execution Team and present study status to leadership.
• Support clinical study reports, regulatory submissions, and investigator meetings.
• Mentor CTMs, CTAs, and CRAs; oversee multiple studies or a program.

Skills

Clinical Operations

Vendor Oversight

Regulatory Knowledge

Budget Management

Project Leadership

Education

Bachelor's degree in life sciences

Tools

CTMS

eTMF

EDC

IRT systems

Job description

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 elevate 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