Clinical Trial Manager/Senior Clinical Trial Manager

Equillium•San Diego, CA

23h

About The Position

The Clinical Trial Manager (CTM) or Senior Clinical Trial Manager is responsible for planning, executing, and delivering one or more clinical studies across the company’s development portfolio. The role provides operational leadership from study start-up through closeout, ensuring trials meet protocol requirements, ICH-GCP, applicable regulations, and company quality standards. The Senior CTM is the primary operational lead for assigned studies and works with cross-functional teams, CROs, vendors, and investigator sites to manage timelines, budgets, quality oversight, and risk mitigation. The position balances strategic thinking and hands-on execution in a fast-paced biotech environment. It reports to the Vice President, Clinical Operations. The role leads operational planning, execution, and closeout of Phase I–III trials; coordinates across functional teams; provides operational input into protocols and study plans; and manages study timelines, forecasts, risks, and performance metrics. It oversees start-up and site activities, monitors trial progress, resolves issues, and conducts oversight visits as needed. The CTM leads CRO and vendor selection and oversight, manages vendor deliverables and performance, and reviews study budgets, forecasts, contracts, change orders, and invoices. The role also oversees clinical trial systems and study documentation, including CTMS, eTMF, EDC, IRT/RTSM, dashboards, and Trial Master Files, supporting system requirements, testing, improvements, and inspection readiness. The role ensures studies comply with ICH-GCP, regulatory requirements, company SOPs, and quality standards; supports audits and inspections; helps resolve quality and compliance issues; and contributes to process improvement and operational excellence.

Requirements

Bachelor’s degree in Life Sciences, Nursing, or a related scientific discipline.
At least 8 years of clinical research experience in the biotechnology, pharmaceutical, or CRO industry.
At least 3 years of clinical trial management responsibility.
Proven experience leading global Phase I–III clinical trials from start-up through closeout.
Demonstrated success managing CROs, specialty vendors, investigator sites, study budgets, timelines, and deliverables.
Experience supporting sponsor audits, regulatory inspections, and inspection-readiness activities.
Strong working knowledge of ICH-GCP, FDA, EMA, and global clinical trial regulations.
Experience with CTMS, eTMF, EDC, IRT/RTSM, and related clinical trial technologies.
Demonstrated ability to lead and influence cross-functional teams in a matrix environment.
Strong project management, organizational, and risk management skills.
Excellent communication, collaboration, and stakeholder management abilities.
Ability to independently manage multiple priorities in a fast-paced environment.
Strong problem-solving skills and a proactive, solutions-oriented mindset.
Detail-oriented, with commitment to quality, compliance, and operational excellence.
Comfort balancing strategic leadership with hands-on execution.
Highly organized with exceptional attention to detail and ability to maintain accuracy across multiple priorities and deliverables.
Ability to build credibility, foster collaboration, and drive accountability across cross-functional teams and external partners.
Strong interpersonal skills and ability to develop productive relationships, navigate challenging situations, and influence stakeholders at all levels.
Strong written, verbal, and presentation communication skills, tailored to diverse audiences.
Proactive, resourceful, and solutions-oriented, with willingness to independently identify issues and drive resolution.
Sound judgment and decision-making skills, including ability to assess risk, balance priorities, and make informed recommendations.
Adaptability and resilience in a dynamic, fast-paced, evolving biotechnology environment.
Emotional intelligence, including self-awareness, empathy, professionalism, and ability to navigate complex team dynamics.
Collaborative approach that values transparency, open communication, and shared organizational goals.
Strong critical thinking and problem-solving capabilities with a continuous improvement mindset.
Self-motivated and accountable, with ownership, initiative, and follow-through.
High standards of integrity, ethics, and professionalism.
Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint, Outlook, Project) and ability to rapidly learn and adopt new systems and technologies.
Willingness to travel up to 20–30%.

Nice To Haves

Advanced degree.
Experience in immunology, inflammation, autoimmune disease, rare disease, or other complex therapeutic areas.
Prior experience in a small biotech, growth-stage, or resource-constrained environment.

Responsibilities

Lead operational planning, execution, and closeout of Phase I–III clinical trials to meet study objectives, timelines, budgets, regulations, and company procedures.
Coordinate study activities across Clinical Development, Data Management, Biostatistics, Regulatory Affairs, Medical Writing, Quality, CMC, Translational Sciences, and other functions.
Provide operational input into protocol development, study design, feasibility assessments, investigator selection, enrollment strategy, and execution plans.
Develop and maintain study timelines, forecasts, risk management plans, and key performance indicators.
Identify, assess, and mitigate operational risks affecting study quality, timelines, budget, or patient safety.
Oversee study start-up activities, including vendor selection, site activation, contracting support, and enrollment readiness.
Monitor trial progress and performance metrics, resolve issues, and escalate critical challenges in a timely manner.
Conduct site visits, co-monitoring visits, and other oversight activities as needed.
Identify opportunities to improve processes, efficiency, and study execution.
Lead CRO and vendor selection, including RFP development, proposal evaluation, bid defenses, and contract scope review.
Act as primary sponsor contact for CROs and key vendors, ensuring accountability for deliverables, quality, timelines, and budget.
Conduct vendor governance and performance reviews using metrics and oversight meetings.
Review and manage study budgets, forecasts, change orders, contracts, and invoices with Finance and external partners.
Ensure vendor activities align with study objectives, regulations, and company expectations.
Oversee clinical trial systems, including CTMS, eTMF, EDC, IRT/RTSM, and other study technologies.
Ensure study systems, documentation, and Trial Master Files are complete, accurate, and inspection-ready.
Partner with vendors and functional teams to define system requirements, user access, reporting needs, and performance metrics.
Develop and maintain dashboards and operational reports to monitor enrollment, site performance, TMF health, milestones, and study metrics.
Support system implementations, user acceptance testing, process enhancements, and adoption of new technologies.
Ensure studies comply with ICH-GCP, applicable regulatory requirements, company SOPs, and quality standards.
Support inspection readiness and participate in audits, inspections, and quality assessments involving sites, CROs, and vendors.
Identify and escalate quality and compliance issues and support their resolution, including CAPA development and root cause investigations as applicable.
Contribute to developing and improving SOPs, processes, templates, and operational tools.
Use quality metrics, lessons learned, and industry best practices to drive operational excellence.
Travel up to 20–30%, including for investigator site visits, vendor meetings, and company-related business activities.