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

COMPANY DESCRIPTION

Tissium is a mission-driven medical device company founded in 2013, headquartered in Paris, with a production facility in Roncq (near Lille) and an office in Boston. We are dedicated to creating a new era of body repair by leveraging our biopolymer platform to develop innovative solutions in surgery for a positive impact on patients' lives.

Tissium’s technology is based on research and intellectual property from the laboratories of Professor Robert Langer (MIT) and Professor Jeffrey M. Karp (Brigham and Women's Hospital), who co-founded the company with Christophe Bancel (CEO) and Maria Pereira (Deputy CEO & Chief Innovation Officer).

We are developing polymers for atraumatic tissue repair in various applications. Today, these polymers are used for sutureless nerve repair, hernia repair, and cardiovascular sealing. Since our inception, we have raised a total of 170 million euros. Our latest fundraising round, which concluded in April 2023, resulted in 50 million euros in additional funding. This infusion of capital provides us with the necessary resources to finance the commercialization of our first products.

RESPONSIBILITIES

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.

• 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.

• Coordinates 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.

YOUR BACKGROUND

• 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