Senior Clinical Trial Manager

Regulatory Jobs; Boston (MA); On-site; USD 165,000 - 185,000; Full time

Benefits offered by this job

Unlimited PTO

Lifestyle spending account

Commuting reimbursement

Job summary

Rapport Therapeutics in Boston is seeking an experienced Clinical Operations Lead to drive a global Phase 1–III program across sites. You will partner with the COL to ensure study start-up, monitoring, and close-out with rigorous GCP and ICH adherence.

You'll oversee CTMS/eTMF workflows, vendor management, and trial documentation while coordinating cross-functional teams and communicating updates to stakeholders. Onsite schedule is Mon-Wed at our Boston office.

Qualifications

• 6–8 years of clinical operations experience in biotech or pharma.
• Solid understanding of GCP, ICH guidelines and the clinical development process.
• Experience with CTMS and eTMF systems.

Responsibilities

• Provide support to the Clinical Operations Lead in planning, execution, and oversight of a global Phase 3 trial from start-up to close-out.
• Develop, review, and track study-related documents with cross-functional teams.
• Oversee start-up activities to accelerate country and site activations.
• Oversee CROs and vendors, monitor performance, and ensure high-quality deliverables.
• Track timelines, enrollment, deviations, data trends, and sample management with CRO and internal stakeholders.
• Maintain trial documentation and ensure inspection readiness.
• Contribute to inspection readiness and ensure compliance with GCP and SOPs.
• Identify and resolve site risks and foster positive site relationships.
• Coordinate internal meetings and cross-functional study meetings.

Skills

Clinical operations experience

GCP & ICH knowledge

Cross-functional collaboration

Documentation & compliance

Education

Bachelor’s degree in life sciences or healthcare

Tools

CTMS

eTMF

Job description

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 in primary generalized tonic‑clonic seizures (PGTCS) 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!

We anticipate hiring for this role in mid-Q4. This role is located in Boston, MA with an onsite requirement of Monday-Wednesday every week.

Your impact:

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.

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.

Must‑Haves:

• 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.

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:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this? We tell you about our hiring range now - we expect the hiring range for the role to be $165,000 to $185,000. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company.

Hybrid Work Environment:

We prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office Monday‑Wednesday to create more opportunities for innovation, collaboration, and connection.

Rapport Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

CCPA disclosure notice can be found here.