Senior Clinical Trial Manager

In this role, you’ll work with our Clinical Operations Lead to help keep our Bipolar Mania trials running smoothly. It’s a hands-on, high-impact role on a fun, driven team where you’ll grow fast and make a real difference.

• 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.

• Bachelor’s degree preferably in life sciences or healthcare related field.
• 6-8 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.

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.