Our client is a well funded clinical-stage biotechnology company focused on developing innovative therapies for patients with immune-mediated and inflammatory diseases. As the organization continues to advance its pipeline, they are seeking an experienced and highly motivated Associate Director or Senior Clinical Trial Manager (CTM) to provide operational leadership for ongoing and upcoming clinical studies.
Reporting to Clinical Operations leadership, this person will be responsible for the day-to-day management and oversight of clinical trials, CROs, and study vendors. This individual will play a critical role in study start-up, site activation, enrollment strategy, risk management, and overall trial execution while collaborating closely with cross-functional stakeholders across the organization.
This is an excellent opportunity for a clinical operations professional who enjoys working in a collaborative, fast-paced biotech environment and wants to make a meaningful impact on the development of novel therapies.
Key Responsibilities
Clinical Trial Execution
- Lead the operational management of assigned clinical studies from start-up through closeout.
- Provide oversight and management of CROs, vendors, and external partners to ensure studies are executed according to timelines, budget, quality standards, and regulatory requirements.
- Monitor study progress and proactively identify operational risks, developing mitigation strategies as needed.
- Support site selection, site activation, enrollment planning, and patient recruitment initiatives.
- Ensure studies are conducted in accordance with GCP, ICH guidelines, SOPs, and applicable regulatory requirements.
Vendor & CRO Management
- Serve as the primary operational contact for CROs and study vendors.
- Review study metrics, timelines, deliverables, and budgets.
- Facilitate vendor governance meetings and ensure accountability for study milestones and performance expectations.
- Escalate issues appropriately and drive resolution of operational challenges.
Cross-Functional Collaboration
- Partner closely with Clinical Development, Medical Affairs, Regulatory Affairs, Data Management, Biostatistics, Pharmacovigilance, and Clinical Supply teams.
- Contribute operational expertise to broader program planning and development discussions.
- Ensure alignment across internal stakeholders regarding study timelines, objectives, and deliverables.
Study Start-Up & Documentation
- Support protocol review and operational feasibility assessments.
- Assist in the development, review, and maintenance of study-related documents, including:
- Clinical Trial Management Plans
- Study Manuals
- Vendor Oversight Plans
- Enrollment and Recruitment Plans
- Risk Management Documentation
- Study Tracking Tools and Reports
- Participate in investigator meetings and study team meetings as needed.
Risk Management & Oversight
- Proactively identify study risks and implement mitigation strategies.
- Monitor enrollment performance and study metrics.
- Ensure inspection readiness and compliance throughout study execution.
- Support audit and inspection activities when required.
Qualifications:
Required
- Bachelor's degree in Life Sciences or related field.
- 5+ years of clinical operations experience within biotechnology, pharmaceutical, or CRO environments.
- Prior experience independently managing Phase I, II, and/or III clinical studies.
- Strong CRO and vendor oversight experience.
- Working knowledge of ICH-GCP guidelines and FDA regulations.
- Experience managing study timelines, budgets, and deliverables.
- Strong communication, organizational, and project management skills.
Preferred
- Experience in Immunology, Inflammation, Autoimmune Disease, Rheumatology, Dermatology, Gastroenterology, or related therapeutic areas.
- Experience working in small or emerging biotechnology companies.
- Global study experience.
- CTMS and eTMF management experience.