Clinical Trial Manager

Responsibilities: Lead the planning, implementation, execution, and oversight of a global Phase III clinical study in alignment with the protocol, budget, milestones, and regulatory requirements. Serve as the primary sponsor contact for the contract research organization (CRO) and managed vendors, overseeing performance, KPIs, monitoring quality, and managing risks, issues, and escalations. Provide strong sponsor-side operational leadership across CRO and vendor oversight, global sites, timelines, and trial quality. Coordinate and lead cross-functional study team activities across Clinical Development, Data Management and Statistics, Regulatory, Safety, Drug Supply, Finance, and other key functions to ensure seamless execution. Support new site identification and selection as enrollment expands, including in APAC and European regions, and ensure sites are activated and supported effectively. Oversee Trial Master File (TMF) quality to maintain inspection readiness, including management of risk, issue, and decision logs and corrective and preventive action (CAPA) activities as needed. Support the development and management of contracts and change orders, including vendor and site budgets, to ensure financial control and alignment with study needs. Contribute to the review of clinical data to support data quality, consistency, and readiness for analysis and regulatory submission. Oversee study supplies and logistics to ensure sites have the necessary materials and drug supply to support uninterrupted trial conduct. Lead or support site and vendor closeout activities, ensuring proper documentation, data reconciliation, and regulatory compliance. Operate effectively in a mid-study environment with tight timelines and evolving enrollment and site needs, proactively identifying and resolving operational challenges. Maintain a strong focus on inspection readiness and compliance with ICH-GCP and applicable clinical research regulations throughout the study lifecycle. Collaborate with global stakeholders and regional teams, including those in Europe and APAC, to ensure consistent execution and communication across regions. Essential SkillsProven ability to independently run or oversee a global clinical study, ideally at the Phase III stage. Strong sponsor-side CRO and vendor oversight experience, including performance management, KPI tracking, and issue escalation. Demonstrated ability to operate effectively in a mid-study environment with tight timelines and changing enrollment and site needs. Strong knowledge of ICH-GCP and applicable clinical research regulations, with a particular focus on inspection readiness. Demonstrated cross-functional leadership skills and the ability to collaborate effectively with global teams, including Europe and APAC.Hands-on experience in clinical trial operations and vendor management. Degree in biomedical, pharmaceutical, life sciences, or a related discipline; MSc preferred. Target of 57 years of relevant clinical operations experience, specifically with meaningful Clinical Trial Manager experience; 35 years may be considered for a strong high-achiever capable of performing the role. Sponsor-side experience strongly preferred; profiles with only CRO experience are not the primary target. Experience leading global Phase III studies preferred. Willingness to travel as required for study needs and stakeholder engagement. Additional Skills & QualificationsMSc in biomedical, pharmaceutical, life sciences, or a related field is preferred and considered an asset. Global Phase III study leadership experience is highly desirable. Rare disease clinical trial experience is a significant plus. Biotech experience is a significant advantage, though strong candidates from large pharmaceutical environments may also be considered. Proven ability to manage complex stakeholder relationships across CROs, vendors, and internal cross-functional teams. Strong organizational, communication, and problem-solving skills, with a focus on proactive risk identification and mitigation. Motivation to take on a highly visible leadership role in a critical global ultra-rare disease program, with potential for long-term continuity. Interest in a career path that offers broad sponsor-side ownership across CRO and vendor oversight, global site management, TMF and inspection readiness, and cross-functional operations.

Work Environment: This position is primarily remote, offering flexibility while maintaining strong collaboration with global teams. Candidates based in the Northeast are preferred, with the Massachusetts/Boston area considered a plus due to the ability to come into the office periodically for in-person meetings and collaboration. The role involves working with global stakeholders across multiple time zones, including Europe and APAC, which may occasionally require flexible hours to support cross-regional communication. The environment is fast-paced and execution-focused, centered on a high-stakes global Phase III ultra-rare disease program. The Clinical Trial Manager will work extensively with CROs, vendors, and internal cross-functional teams using standard clinical trial technologies and systems to manage timelines, TMF quality, inspection readiness, and study documentation. Travel may be required to attend key meetings, site visits, or vendor engagements, depending on study needs.

Job Type & Location: This is a Contract position based out of Lexington, MA.

Pay and Benefits: The pay range for this position is $70.00 - $75.00/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)