Senior Clinical Trial Manager

Chroma Medicine; Boston (MA); Hybrid; USD 90,000 - 150,000; Full time

Job summary

An innovative biotechnology company is seeking a Senior Clinical Trial Manager to lead the planning and execution of a pivotal clinical trial. This role offers a unique opportunity to drive the success of groundbreaking therapies aimed at treating chronic hepatitis B and D. You'll work in a collaborative environment, overseeing trial activities, managing budgets, and ensuring compliance with regulatory standards. Join a passionate team dedicated to delivering transformative solutions in genetic medicine. If you thrive in a dynamic setting and are eager to make an impact in the biotech field, this position is perfect for you.

Qualifications

• 8+ years of experience in cross-functional trial management in biotech or CRO.
• Solid understanding of GCP, ICH guidelines, and relevant regulations.

Responsibilities

• Oversee global clinical trial activities and manage internal/external stakeholders.
• Ensure site feasibility, selection, and start-up for clinical trials.

Skills

Stakeholder Management

Clinical Trial Management

Risk Management

Communication Skills

Budget Management

Education

Bachelor's degree in Life Sciences

Tools

Clinical Trial Management Systems

Job description

nChroma Bio is a pioneering biotechnology company redefining the future of in vivo targeted genetic medicine to treat a wide array of diseases and bring cures to patients. The company’s integrated product engine tackles significant limitations of existing genetic medicine approaches by enabling safe, precise and specific in vivo delivery. nChroma’s near clinical-stage development candidate, CRMA-1001, is a liver-targeted therapy in development as a potential functional cure for chronic hepatitis B and hepatitis D that leverages the power of epigenetics, nature's innate mechanism for gene regulation. Guided by a world-class team at the forefront of genetic medicine, founded by renowned pioneers in the field, and supported by top-tier investors, the company is uniquely positioned to deliver groundbreaking therapies with programmable tissue specificity, unlocking highly potent, durable and targeted gene regulation for the liver and beyond.

We’re building a culture and organization to support this important mission, bringing together individuals that thrive in a supportive environment where diverse perspectives and a passion for discovery drive cutting-edge science and breakthrough medicines.

ABOUT THE ROLE

As a Senior Clinical Trial Manager, reporting to the VP, Clinical Operations, you will have the unique opportunity to be at the forefront of planning, implementation and execution of nChroma Bio’s FIH clinical trial of our HBV epigenetic editor CRMA-1001. You will oversee the global end-to-end activities of the clinical trial, with a focus on start-up activities, CRO/vendor oversight, and management of internal and external cross-functional stakeholders. This role empowers you to thrive in your expertise while driving success and helping nChroma deliver cures to patients. This is an opportunity to join a talented, passionate, and engaged team working to foster a collaborative environment where cutting-edge science meets a positive, forward-thinking mindset.

We are hiring at our Boston, Massachusetts site. We are open to a hybrid work schedule of 2-3 days per week in our Boston office.

HOW YOU’LL CONTRIBUTE

• Actively support the day-to-day execution of global clinical trial activities across key operational areas.
• Ensure oversight of site feasibility, selection and start-up, clinical monitoring and site management.
• Serve as the primary Sponsor contact for all clinical trial stakeholders both internally and externally, including for CROs/vendors.
• Accountable for clinical trial financial management, and change control, including review and approval of vendor invoices, investigator grants and pass-through costs, budget reconciliations and forecasting.
• Organize and participate in site training, including investigator meetings.
• Oversee and contribute to the development and implementation of cross-functional clinical trial documents, such as protocols and clinical study reports.
• Oversee and/or assist with IRB/IEC and regulatory submissions; liaise with global team to ensure alignment with study objectives and milestones.
• Drive positive, solution-oriented communication and ensure accountability across all levels.
• Perform risk management, including identifying, tracking, and evaluating potential risks and mitigation strategies.
• Support the coordination of study-specific quality audits and regulatory authority inspections, acting as a Subject Matter Expert (SME).
• Train and mentor other Clinical Operations personnel as applicable, providing leadership, oversight and motivation.

WHAT YOU’LL BRING

• Bachelor’s degree from an accredited college or university, or equivalent work experience, preferably in Life Sciences required.
• 8+ years’ experience in cross-functional trial management in a pharmaceutical, biotechnology or CRO.
• Extensive experience in global clinical trial execution, with strong stakeholder management and communication skills.
• Demonstrated success in managing CROs and vendors, maintaining timelines, and overseeing budgets with precision.
• Solid understanding of clinical trial methodology, GCP, ICH guidelines, and relevant regulations.
• Proven track record of experience maintaining positive relationships with sites, CROs, and third-party vendors.
• Demonstrated ability to lead with accountability, meet timelines, foster a collaborative team environment, and drive solutions proactively.
• Ability to travel periodically (up to 20%)

nChroma Bio is an equal opportunity employer, providing equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation or genetics. In addition to federal law requirements, nChroma Bio complies with applicable state and local laws governing nondiscrimination in employment.