Lead Clinical Study Manager
This role sits within a values-driven, R&D-focused environment committed to meaningful work and global impact. The organization offers a collaborative, inclusive culture guided by the mission to deliver better health outcomes worldwide. As a Lead Clinical Study Manager, you will be a key contributor to that mission.
location: Lexington, Massachusetts
job type: Contract
salary: $120 - 135 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
How You Will Contribute
- Lead and manage complex clinical trials, ensuring delivery against timelines and budgets.
- Maintain compliance with global regulatory requirements and uphold strong data integrity.
- Optimize team performance through effective resource and project management.
- Drive cross-functional collaboration within clinical operations.
- Influence project direction through strong leadership and decision-making.
- Solve complex operational issues using analytical and industry expertise.
- Analyze clinical data to support strategy and decision-making.
- Mentor and train junior team members to support their professional development.
- Lead operational planning, strategy, and execution for assigned clinical trials.
- Provide subject-matter expertise for protocol synopses, final protocols, and study documents.
- Challenge teams to ensure operational and patient/site feasibility.
- Validate study budgets and manage financial impacts.
- Support country/site feasibility and selection, providing strategic alignment and local insights.
- Ensure timelines align with program and clinical development plans.
- Oversee onboarding of new team members and vendors.
- During early engagement with Strategic Partners/CROs, lead development of operational strategy and risk-management plans.
- Provide oversight, guidance, and issue-resolution support to CROs and vendors.
- Manage study budget planning, external spending, and regular financial reviews with Program Leaders and Finance.
- Oversee vendor selection, budget/contract negotiations, and performance management, escalating issues as needed.
- Review and approve monitoring plans/documents and periodically assess monitoring outputs.
- Review and endorse relevant study plans.
- Manage or attend study team meetings and ensure agendas/minutes are appropriately maintained.
- Review protocol deviation trends and support mitigation strategies.
- Track issues, risks, and decisions at the study level, ensuring timely resolution and mitigation.
- Partner with Data Management to validate database timelines and align strategy with data delivery and CSR readiness.
- Ensure ongoing inspection readiness and support regulatory inspections as required.
- Represent the Lead Clinical Study Manager function in cross-functional initiatives or working groups.
- Support onboarding and mentorship of new or junior CSMs.
- Provide assistance to Program Leadership as needed.
qualifications:
- BS/BA in a health-related, life science, or technology field, or equivalent experience.
- Advanced degree (Master's/Doctorate) and relevant training may supplement experience requirements.
- 6+ years in the pharmaceutical or CRO industry, including 4+ years in clinical study management/oversight.
- Experience must include early-phase or Phase 2/3 studies, with global/multiregional exposure.
- Experience across multiple therapeutic areas is a plus.
- Strong knowledge of global regulatory and compliance requirements (US CFR, EU CTD, ICH GCP) and awareness of local country requirements.
- Demonstrated excellence in project/program management and matrix leadership.
- Exceptional communication skills.
skills: Clinical Study Protocol Summaries
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
