Clinical Trial Manager or Associate Clinical Trial Manager

Responsibilities

• In this role, you'll work with our Clinical Operations Leads to help keep trials running smoothly across multiple indications. It's a hands-on, high-impact role on a fun, driven team where you'll grow fast and make a real difference.
• Your day-to-day:
• 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.

Requirements

• Bachelor's degree preferably in life sciences or healthcare related field.
• 5+ years of clinical operations experience within the biotech or pharma industry required
• Title and level commensurate with experience
• 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.
• What makes Rapport special:
• 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.
• Your Compensation:

Benefits

Additional Information

When our people share why they joined Rapport and love it here, it comes down to three things: the science, the mission, and the team. At Rapport, we're driven by a passion for developing precision neuromedicines with the potential for fewer side effects, enabling patients and their families to enjoy healthier, more fulfilling lives. And we're doing this with extraordinary science and awesome people (affectionately called Rapptors). Our innovative scientific platform is centered on Receptor Associate Proteins (RAPs). RAPs are a component of neuronal receptor complexes, which play a crucial role in regulating receptor assembly and function. This precision approach has the potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead program, RAP-219. Our first indication targets focal epilepsy with additional clinical trials for neuropathic pain and bipolar disorder. The strength of Rapport comes from our Rapptors - who are united by our mission to improve patients lives. We bring the heart and hustle to advance our science forward, always staying true to our core values. We hope you're as excited about this opportunity as we are! This role is based in Boston, MA with onsite presence required Monday-Wednesday

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