Clinical Trial Manager/Senior Clinical Trial Manager

Equillium•San Diego, CA

14h•$185,000 - $195,000

About The Position

The (Senior) Clinical Trial Manager (CTM) plans, executes, and delivers one or more clinical studies across the company's development portfolio. The role provides operational leadership from study start-up through closeout, ensuring compliance with protocol requirements, ICH-GCP, applicable regulations, and company quality standards. The Senior CTM is the primary operational lead for assigned studies and collaborates with cross-functional teams, CROs, vendors, and investigator sites to manage timelines, budgets, quality oversight, and risk mitigation. The role combines strategic thinking with hands-on execution in a fast-paced biotechnology environment and supports a culture of quality, compliance, and operational excellence. This position reports to the Vice President, Clinical Operations.

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, including at least 3 years with 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 clinical systems including CTMS, eTMF, EDC, IRT/RTSM, and related 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.
Attention to detail and commitment to quality, compliance, and operational excellence.
Ability to balance strategic leadership with hands-on execution in a small biotech setting.
Highly organized, with exceptional attention to detail and the ability to maintain accuracy across multiple priorities and deliverables.
Strong leadership presence and ability to build credibility, foster collaboration, and drive accountability across cross-functional teams and external partners.
Excellent interpersonal skills and ability to develop productive relationships, navigate challenging situations, and influence stakeholders at all levels.
Strong written, verbal, and presentation skills, tailored to diverse audiences.
Proactive and resourceful, with willingness to identify issues independently and drive resolution.
Sound judgment and decision-making skills, including the ability to assess risk, balance competing priorities, and make informed recommendations.
Adaptable and resilient in a dynamic, fast-paced, and evolving biotechnology environment.
Demonstrated 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.
Proficient with Microsoft Office Suite (Excel, Word, PowerPoint, Outlook, Project) and able to rapidly learn and adopt new systems and technologies.
Willingness to travel up to 20–30%, including investigator site visits, vendor meetings, and company-related business activities.

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, delivering study objectives on time, within budget, and in compliance with regulations and company procedures.
Coordinate across Clinical Development, Data Management, Biostatistics, Regulatory Affairs, Medical Writing, Quality, CMC, Translational Sciences, and other functional areas.
Provide operational input into protocol development, study design, feasibility assessments, investigator selection, enrollment strategy, and study 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 study challenges in a timely manner.
Conduct site visits, co-monitoring visits, and other oversight activities as needed to support protocol compliance, data quality, and site engagement.
Identify opportunities to improve processes, increase efficiency, and enhance 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, overseeing accountability for deliverables, quality, timelines, and budget.
Conduct vendor governance and performance reviews using metrics and regular oversight meetings.
Review and manage study budgets, forecasts, change orders, contracts, and invoices in partnership with Finance and external partners.
Ensure vendor activities align with study objectives, regulatory requirements, 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 throughout the study lifecycle.
Partner with vendors and functional teams to define system requirements, user access, reporting needs, and performance metrics.
Develop and maintain study dashboards and operational reports covering 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, escalate, and support resolution of quality and compliance issues, including CAPA development and root cause investigations as applicable.
Contribute to development and continuous improvement of SOPs, processes, templates, and operational tools.
Drive operational excellence using quality metrics, lessons learned, and industry best practices.