Clinical Trial Manager

Clinical Trial Manager

The Clinical Trial Manager leads the planning, execution, and delivery of Phase 1 clinical studies in healthy volunteers, including first-in-human (FIH), single and multiple ascending dose (SAD/MAD), food effect, bioavailability/bioequivalence (BA/BE), human abuse potential (HAP), thorough QT (TQT), drug–drug interaction (DDI), and other early-phase studies. This role oversees end-to-end study operations, manages vendors and clinical partners, ensures regulatory compliance and inspection readiness, and collaborates closely with cross-functional teams to support clinical development objectives.

Responsibilities:

• Plan, execute, and deliver Phase 1 clinical studies in healthy volunteers, including FIH, SAD/MAD, food effect, BA/BE, HAP, TQT, DDI, and other early-phase trials.
• Develop and manage detailed study timelines, budgets, forecasts, and resource plans to ensure studies are delivered on time and within budget.
• Provide operational input into protocol development and study design, including feasibility assessments and risk mitigation strategies.
• Oversee contract research organizations (CROs), Phase 1 units, laboratories, and clinical vendors to ensure high-quality performance and adherence to study objectives.
• Ensure compliance with FDA regulations, ICH-GCP guidelines, internal standard operating procedures (SOPs), and applicable global regulatory requirements.
• Partner with Clinical Pharmacology, Translational Medicine, Regulatory Affairs, Biostatistics, Medical, Safety, and Clinical Supply teams to support study execution and development goals.
• Maintain inspection readiness throughout the study lifecycle and oversee eTMF quality, completeness, and timely filing of essential documents.
• Monitor study progress, enrollment, safety, data quality, and operational metrics, proactively identifying and addressing risks and issues.
• Support IND submissions, protocol amendments, regulatory inspections, audit readiness, study closeout, and clinical study report (CSR) activities.
• Participate in SOP development, process mapping, and other departmental initiatives to enhance operational efficiency.
• Mentor and develop Clinical Operations staff while promoting operational excellence, process improvements, and a culture of quality and accountability.
• Help prepare for safety review and data committee meetings in collaboration with senior clinical operations leadership.
• Support current senior clinical operations leaders in managing ongoing Phase 1 programs and related operational activities.
• Effectively multi-task across multiple studies or workstreams while maintaining high standards of quality and compliance.
• Contribute as a strong team player, fostering collaboration and clear communication across internal and external stakeholders.

Essential Skills:

• B.S., M.S., or Ph.D. in basic sciences.
• 10+ years of Clinical Operations experience within biotechnology, pharmaceutical, or CRO environments.
• Minimum of 3 years of direct experience managing Phase 1 studies in healthy volunteers.
• Recent Phase 1 study experience within the past couple of years.
• In-human clinical study experience; bioanalytical-only experience is not sufficient.
• Clinical Operations experience; pharmacology-only experience is not sufficient.
• Expertise in clinical trial management and subject safety oversight.
• Strong vendor management skills, including oversight of CROs, Phase 1 units, laboratories, and clinical service providers.
• Proficiency in clinical research and project management within early-phase trials.
• Deep understanding and competent application of SOPs, ICH guidelines, global regulations, ethics, and compliance standards.
• Ability to work effectively in a team environment and collaborate with cross-functional stakeholders.
• Ability to manage multiple priorities simultaneously while maintaining quality and timelines.

Additional Skills & Qualifications:

• CNS or psychiatry experience is helpful but not required.
• Oncology-only Phase 1 experience is not sufficient for this role.
• Experience preparing for safety review and data committee meetings under senior clinical operations leadership.
• Demonstrated ability to support senior clinical operations leaders on complex Phase 1 programs.
• Strong communication and interpersonal skills to build effective relationships with internal teams and external partners.
• Proven ability to contribute to SOP development and process improvement initiatives.
• Track record of fostering a culture of quality, accountability, and operational excellence.
• Adaptability to work in a dynamic, fast-paced clinical development environment.

Work Environment:

This position operates in a remote work environment, offering flexibility while supporting global Phase 1 clinical studies. You will collaborate virtually with cross-functional teams, external partners, and clinical vendors, using standard clinical trial management systems, electronic trial master file (eTMF) platforms, and common communication tools to manage study operations. The role emphasizes a professional, results-oriented culture with opportunities for extension and long-term engagement, and you will work closely with experienced colleagues who report high satisfaction with the organization.

Job Type & Location:

This is a Contract position based out of Waltham, MA.

Pay and Benefits:

The pay range for this position is $85.00 - $91.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type:

This is a fully remote position.

Application Deadline:

This position is anticipated to close on Sep 30, 2026.