Clinical Study Manager

Hengrui USA; Waltham (MA); Hybrid; USD 110,000 - 145,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Paid time off

401k with company match

Life insurance

Job summary

Hengrui USA in Waltham, MA seeks a Clinical Study Manager to lead end-to-end study execution (Phase I–III), oversee CROs, manage budgets, and ensure operational excellence across programs in oncology and immunology.

In this hybrid role, you will coordinate cross-functional teams, plan studies, monitor timelines and KPIs, and report progress to senior management, partnering with the Clinical Operations Director to sustain program continuity.

Qualifications

• Bachelor's degree or above in Life Sciences, Pharmacy, Medicine, or a related discipline.
• Minimum 3–4 years of relevant clinical study management experience.
• Experience in Phase I–III clinical trials, preferably oncology and immunology.
• Global clinical study management experience with exposure to US and Europe.

Responsibilities

• End-to-End Study Management: Lead and oversee planning, initiation, execution, monitoring, and close-out of global Phase I–III clinical studies.
• Global Study Operations: Manage activities across multiple countries/regions, especially US and Europe, aligning with timelines, budgets, and quality.
• CRO & Vendor Oversight: Define and monitor KPIs, evaluate performance, and drive corrective actions.
• Study Planning & Budget Management: Develop study plans, timelines, resources, and budgets.
• Cross-Functional Collaboration: Lead regular study team meetings and align internal/external stakeholders.
• Risk & Issue Management: Proactively identify and mitigate study-related risks.
• Management Reporting: Provide regular study status updates and escalations to leadership.
• Operational Excellence: Establish consistent study management practices with the Clinical Operations Director.

Skills

Study management

Budgeting

CRO oversight

Cross-functional collaboration

Project management

Vendor management

Communication

Multinational coordination

Education

Bachelor's degree in Life Sciences/Pharmacy/Medicine

Job description

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 Responsibilities

• End-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 & Experience

• Bachelor'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 Profile

• Candidates 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.
• 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.