Clinical Trial Manager / Associate Clinical Trial Manager
About The Position
ClinChoice is seeking a Clinical Trial Manager / Associate Clinical Trial Manager to join one of our sponsor partners, a Boston-based biotech company focused on CNS disorders. This is a direct-hire, hybrid position requiring three days per week in the office. In this role, you will partner closely with Clinical Operations leadership to support the planning and execution of global clinical trials across multiple indications. It is a highly visible, hands-on opportunity with significant impact on study delivery and operational success. The ideal candidate will have 5+ years of clinical operations experience in biotech or pharma, with a strong background managing outsourced global Phase I–III clinical trials and supporting study start-up activities. They will be highly organized, collaborative professional with expertise in CRO/vendor oversight, trial execution, GCP compliance, and cross-functional coordination to support the successful delivery of a global Phase III study. ClinChoice is a global full-service CRO with a strong focus on quality and professional development. As a client-facing role, we are looking for confident candidates with the ability to work independently while establishing a high-trust environment with their client counterparts.
Requirements
- Bachelor’s degree is preferably in life sciences or healthcare related field.
- 5+ years of clinical operations experience within the biotech or pharma industry required
- Experience managing outsourced global clinical trials across Phase I–III.
- Prior involvement in study start-up activities strongly preferred
- Solid understanding of GCP, ICH guidelines, and the clinical development process.
- Experience with clinical trial management systems (CTMS), eTMF, and other operational tools.
- Ability to multitask and flex across projects as priorities and deadlines shift.
- Highly organized with excellent communication and interpersonal skills.
- Strong attention to detail and ability to multitask in a dynamic, fast-paced setting.
- A collaborative team player that takes initiative.
Responsibilities
- Provide support to the Clinical Operations Lead (COL) in the planning, execution, and oversight of a global phase 3 clinical trial from study start-up to close-out.
- Support the development, review and tracking of study-related documents (protocols, ICFs, investigative brochure, monitoring visit reports, etc.) with cross functional team collaboration.
- Support start-up activities to help accelerate country and site activations.
- Oversee CRO and vendors, monitor performance metrics, and ensure timely and high-quality deliverables.
- Track study timelines, enrollment, protocol deviations, data trends, and sample management in partnership with CRO and internal stakeholders.
- Maintain and organize trial documentation (e.g., TMF/eTMF oversight, trackers, meeting minutes) ensuring that study documentation is in a continuous state of inspection readiness.
- Contribute to inspection readiness activities and ensure compliance with GCP and SOPs.
- Help identify and resolve site risks and/or issues to foster positive site relationships.
- Coordinate internal team meetings and participate in cross-functional study meetings.
- Proactively communicate study updates with key internal and external stakeholders.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
