Clinical Trial Manager/Senior Clinical Trial Manager

Overview of Position:

The (Senior) Clinical Trial Manager (CTM) is responsible for the planning, execution, and delivery of one or more clinical studies across the Company's development portfolio. This role provides operational leadership from study start-up through closeout, ensuring trials are conducted in compliance with protocol requirements, ICH-GCP, applicable regulations, and company quality standards.

The Senior CTM serves as the primary operational lead for assigned studies and collaborates closely with cross-functional teams, CROs, vendors, and investigator sites to drive study timelines, budget management, quality oversight, and risk mitigation. In a fast-paced biotech environment, this individual combines strategic thinking with hands-on execution to advance innovative therapies while maintaining a culture of quality, compliance, and operational excellence.

This position reports to the Vice President, Clinical Operations.

Essential Duties & Responsibilities:

Clinical Trial Leadership & Execution

• Lead the operational planning, execution, and closeout of Phase I-III clinical trials, ensuring delivery of study objectives on time, within budget, and in compliance with applicable regulations and company procedures.
• Serve as the primary operational lead and central point of coordination 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 (KPIs).
• Proactively identify, assess, and mitigate operational risks that may impact study quality, timelines, budget, or patient safety.
• Oversee start-up activities, including vendor selection, site activation, contracting support, and enrollment readiness.
• Monitor trial progress and performance metrics, driving issue resolution and timely escalation of critical study challenges.
• Conduct site visits, co-monitoring visits, or other oversight activities as needed to ensure protocol compliance, data quality, and positive site engagement.
• Contribute to organizational growth by identifying opportunities to improve processes, increase efficiency, and enhance study execution.

CRO and Vendor Management

• Lead CRO and vendor selection activities, including RFP development, proposal evaluation, bid defenses, and contract scope review.
• Serve as the primary sponsor contact for CROs and key vendors, ensuring accountability for study deliverables, quality, timelines, and budget.
• Conduct vendor governance and performance reviews, utilizing metrics and regular oversight meetings to drive execution and continuous improvement.
• Review and manage study budgets, forecasts, change orders, contracts, and invoices in partnership with Finance and external partners.
• Ensure alignment of vendor activities with study objectives, regulatory requirements, and company expectations.

Clinical Trial Systems & Operational Oversight

• Provide oversight of clinical trial systems, including CTMS, eTMF, EDC, IRT/RTSM, and other study technologies.
• Ensure study systems, documentation, and Trial Master Files remain 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 to monitor enrollment, site performance, TMF health, milestones, and study metrics.
• Support system implementations, user acceptance testing (UAT), process enhancements, and adoption of new technologies.

Quality, Compliance & Process Improvement

• Ensure studies are conducted in accordance with ICH-GCP, applicable regulatory requirements, company SOPs, and quality standards.
• Support inspection readiness activities 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 the development and continuous improvement of SOPs, processes, templates, and operational tools.
• Drive operational excellence through the use of quality metrics, lessons learned, and industry best practices.
  
  

Qualifications:

Education

• Bachelor's degree in Life Sciences, Nursing, or a related scientific discipline required.
• Advanced degree preferred.

Experience

• 8+ years of clinical research experience within the biotechnology, pharmaceutical, or CRO industry, including at least 3 years of clinical trial management responsibility.
• Proven experience leading global Phase I-III clinical trials from start-up through closeout.
• Experience in immunology, inflammation, autoimmune disease, rare disease, or other complex therapeutic areas preferred.
• Demonstrated success managing CROs, specialty vendors, investigator sites, study budgets, timelines, and deliverables.
• Experience supporting sponsor audits, regulatory inspections, and inspection-readiness activities.
• Prior experience in a small biotech, growth-stage, or resource-constrained environment strongly preferred.
• 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.

Key Competencies

• 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 with a proactive, solutions-oriented mindset.
• Detail-oriented with a commitment to quality, compliance, and operational excellence.
• Comfortable balancing strategic leadership with hands-on execution in a small biotech setting.

Success Measures

• Clinical studies delivered on time, within budget, and in compliance with quality standards.
• Effective management of CRO and vendor performance.
• High-quality, inspection-ready study documentation and TMFs.
• Proactive identification and mitigation of study risks.
• Continuous improvement of operational processes, systems, and study execution practices.

Skills & Attributes

• Highly organized with exceptional attention to detail and the ability to maintain accuracy across multiple priorities and deliverables.
• Strong leadership presence with the ability to build credibility, foster collaboration, and drive accountability across cross-functional teams and external partners.
• Excellent interpersonal skills with the ability to develop productive relationships, navigate challenging situations, and influence stakeholders at all levels.
• Effective communicator with strong written, verbal, and presentation skills, tailored to diverse audiences.
• Proactive, resourceful, and solutions-oriented, with a willingness to independently identify issues and drive resolution.
• Sound judgment and decision-making skills, with the ability to assess risk, balance competing priorities, and make informed recommendations.
• Adaptable and resilient, with the flexibility to thrive in a dynamic, fast-paced, and evolving biotechnology environment.
• Demonstrated emotional intelligence, including self-awareness, empathy, professionalism, and the ability to navigate complex team dynamics.
• Collaborative team player who values transparency, open communication, and a shared commitment to organizational goals.
• Strong critical thinking and problem-solving capabilities, with a continuous improvement mindset.
• Self-motivated and accountable, with a high level of ownership, initiative, and follow-through.
• Maintains the highest standards of integrity, ethics, and professionalism in all interactions and activities.
• 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.

Equal Opportunity Employer