Senior Clinical Trial Manager – Boston, MA (M/F/X)

About the role

The Senior Clinical Trial Manager (Boston-based) will assume responsibility for the planning and execution of clinical trials. This individual will be responsible for study timelines and budgets, preparation of study-related materials, relationship management between study sites and CROs, supervision of study activities, identification of project risks, and contingency planning.

The position is based in Boston, Massachusetts, and will play a key role in the successful delivery of Tissium's clinical development programs.

Responsibilities

• Independently manages clinical trials, including those conducted through Contract Research Organizations.
• Assumes overall responsibility for the development of protocols, clinical literature reviews, clinical trial reports, annual reports, risk/benefit analyses, informed consent templates, and other clinical documents.
• Develops study timelines, resource needs, and budgets and ensures accurate tracking and reporting of study metrics.
• Develops study plans including recruitment plan, monitoring plan, safety plan, other study-specific plans. Responsible for oversight of data management activities.
• Covers the design, format and content of study guides and subject instructions; participates in the development of Investigator Brochures.
• Serve as primary contact for TISSIUM functional area representatives and vendors.
• Maintains regular communications with relevant departments such as R&D, Regulatory, Marketing, and others.
• Prepare and disseminate timely internal clinical trial updates.
• Responsible for the selection and day-to-day interaction with CROs and other external partners in the execution of assigned clinical trial(s). Monitors all outsourced activities including CROs, core laboratories and other external and internal partners.

Requirements

• Bachelor's Degree in life sciences, health care or related discipline.
• 6+ years of Trial Management experience in MedTech (medical device), biotech, pharma, or a CRO.
• Working knowledge of Good Clinical Practice (GCP) and US and international regulations for clinical trials.
• Advanced written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology.
• Systematic and efficient planning, decision making, prioritization, negotiation, and coordination skills.
• Thorough knowledge and record of compliance with relevant regulations including but not limited to GCP, ICH E6, 21 CFR, and other relevant regulations and guidances governing conduct of industry-sponsored clinical studies.

Tissium Behaviors & Mindset

• Act with a sense of urgency: Drive a culture of execution, accountability, and timely delivery aligned with critical milestones.
• Embrace calculated risk-taking: Make informed and thoughtful decisions that create positive cross-functional impact.
• Continuously learn and share: Foster a strong learning mindset, encourage knowledge sharing, and support team development.
• Challenge the status quo: Constructively question existing practices to improve systems, processes, and outcomes.
• Balance tactical and strategic thinking: Combine operational excellence with a clear mid-term vision and strategic priorities.
• Assume positive intent: Build trust and foster constructive, respectful, and psychologically safe collaboration across teams.
• Drive active collaboration: Coordinate multiple stakeholders effectively around shared objectives and business priorities.
• Own outcomes: Promote accountability and take responsibility for measurable project results and deliverables.
• Strive for excellence: Drive sustainable improvements in quality, compliance, operational performance, and continuous improvement.

Why Join Us

• A dynamic and stimulating environment, with a culture focused on initiative, learning, and continuous improvement.
• Real opportunities for growth and development, with evolving career paths and tailored training.
• The chance to join an ambitious startup at the forefront of high-impact medical innovation.
• A strong commitment to ESG, embedded in our strategy from day one.
• Athletic conditions: work-life balance, competitive package, and internal mobility (Paris, Roncq, Boston).
• An international and diverse environment, with more than 19 nationalities represented.

Hiring Process

• The journey starts with an interview with Talent Acquisition Manager (30 mins).
• Then a face-to-face (virtual) meeting with the Manager of the department you are applying to join (1 hour).
• This will then be followed by a Technical Interview to validate your practical job-related skills (1 hour).
• At the final stage, shortlisted candidates will be invited to a 90-minute team and culture fit interview, conducted either on-site or by videoconference.