Clinical Study Manager

Job Title: Clinical Study Manager (Manager level)Department: Clinical Operations

Location: Waltham, MA (hybrid; minimum 3 days/week in office).We are opening a Clinical Study Manager role to support the increasing number of global clinical studies, both in oncology and in non-oncology (i.e. immunology) field.

This position will lead end-to-end study execution (Phase I–III), manage CRO oversight, and partner closely with the Clinical Operations Director to ensure operational excellence and continuity across programs.Key ResponsibilitiesEnd-to-End Study Management: Lead and oversee the planning, initiation, execution, monitoring, and close-out of global Phase I–III clinical studies.Global Study Operations: Manage clinical study activities across multiple countries and regions, particularly the US and Europe, ensuring alignment with study objectives, timelines, budgets, and quality expectations.CRO & Vendor Oversight: Lead CRO and vendor management, including defining and monitoring key performance indicators (KPIs), evaluating performance, identifying operational risks, and driving corrective actions when needed.Study Planning & Budget Management: Develop and manage study plans, timelines, resource requirements, and budgets, ensuring effective resource utilization and financial oversight.Cross-Functional Collaboration: Lead regular cross-functional study team meetings, facilitate communication and decision-making, and ensure alignment among internal stakeholders and external partners.Risk & Issue Management: Proactively identify, assess, and mitigate study-related risks and operational challenges to ensure successful study execution.Management Reporting: Provide regular and comprehensive study status updates, progress reports, and escalations to senior management.Operational Excellence: Partner closely with the Clinical Operations Director to establish consistent study management practices, optimize operational processes, and ensure continuity across clinical programs.Qualifications & ExperienceBachelor's degree or above in Life Sciences, Pharmacy, Medicine, or a related discipline.Minimum 3–4 years of relevant clinical study management experience, preferably at the Clinical Study Manager level or above.Experience in managing Phase I–III clinical trials, preferably in oncology and immunology therapeutic areas.Proven experience in global clinical study management, with exposure to clinical operations across the US and Europe.Demonstrated experience in end-to-end study planning, budgeting, execution, and management reporting.Strong CRO oversight and vendor management capabilities, including experience in KPI development, performance monitoring, and vendor accountability.Proven ability to lead and facilitate regular cross-functional clinical study team meetings.Strong project management, organizational, and problem-solving skills, with the ability to manage multiple studies and competing priorities.Excellent interpersonal and communication skills, with the ability to work effectively across international, multicultural, and cross-functional teams.Ability to work independently, demonstrate ownership, and proactively drive study execution and operational excellence.Preferred Candidate ProfileCandidates currently operating at the Clinical Study Manager level are strongly preferred.Senior Manager-level candidates may also be considered if they demonstrate strong clinical study management capabilities and relevant experience.Candidates with combined oncology and immunology experience, particularly in global Phase I–III studies, will be highly preferred.

Benefits

We offer a comprehensive benefits package including medical, dental, and vision insurance; paid time off; a 401k retirement plan with company match. Company paid Life Insurance plan. Additional voluntary benefits (e.g., FSA, DCSA, supplement life insurance, etc.) are available.Schedule: Monday to FridaySalary Range:$120,000–$190,000 annually.