Reporting to Fractyl’s Director of Clinical Operations, the Clinical Project Manager provides leadership on the design, initiation and execution of clinical studies to support both product approvals and market adoption of company products. Responsibilities include the initiation and conduct of clinical studies globally with the Fractyl DMR system (Duodenal Mucosal Resurfacing) in the treatment of Type II Diabetes. As a key member of the team, this individual plays a crucial role to establish the Clinical team’s structure in support of Fractyl’s growth and expansion. With hands-on experience, the Clinical Project Manager collaborates with internal and external stakeholders to support the Clinical team’s global initiatives.
• Manage project timelines and plans in partnership with CRO.
• Support study start-up and execution of assigned clinical trials.
• Work with internal staff and CRO to identify potential investigational sites to meet specific study requirements.
• Participate in site qualification, Site Initiation Visit planning and execution, and site training
• Identify / select /manage vendors including contract research organizations (CRO’s), Core Labs, Electronic Data Capture vendors in conjunction with management.
• Serve as Fractyl liaison for CRO(s), vendors, investigators, study coordinators, physicians, and site staff members.
• Assist with writing and developing clinical protocols, informed consent documents, study manuals, project plans and other study documents as needed.
• Work with internal staff to forecast and manage study supplies.
• Oversight of the Trial Master File (TMF), with support of the Clinical Trial Assistant and CRO
• Work with clinical sites and recruitment vendor(s) to optimize and track the subject recruitment and screening process to reach study recruitment goals.
• Report study progress and metrics regularly to management
• Collaborate with internal staff to negotiate vendor contracts; collaborate with CRO to negotiate site contracts and budgets
• Work with Data Management / CRO to develop CRFs, establish study database and edit check requirements as well as on-going monitoring of data entry compliance and data integrity.
• Serve as liaison with Data Management/CRAs/Biostats group to ensure resolution of data queries.
• Assist with Data Safety Monitoring Board (DSMB) and/or Clinical Event Committee (CEC) oversight.
• Oversight of CRO safety activities, with support from internal Fractyl medical team
• Collaborate with internal supply team to coordinate delivery and shipment of devices and equipment required to conduct clinical investigations.
• Bring a “can-do” attitude to work and deliver on other responsibilities as assigned.
Qualifications and Skills
The selected candidate is expected to deliver high-quality results in the areas of responsibilities outlined above. To do so, the successful candidate must possess a combination of the qualifications and skills below.
· Bachelor degree in a scientific field of study
· PMP® Certification desirable
Professional Work Experience:
• 5 years related experience in Medical Device or related industries
• 2-3 years of experience successfully leading clinical projects and clinical trials
• Excellent knowledge of Good Clinical Practices
• Experience with start-up and management of device trials highly desirable
• PMA experience and Global or European clinical trial experience, experience in working in the Type II diabetes field, or in a related field in the Endocrinology / Endoscopy arena are pluses
• Experience managing internal and external teams
• Excellent interpersonal skills, and demonstrated ability to effectively communicate with sites, investigators and vendors
• Ability to work autonomously under minimal direction, whilst also working well in a team environment
• Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).
Other Essentials and Key Success Factors:
• Experience successfully managing recruitment vendors and recruiting for complex clinical studies
• Experience with electronic data capture
• Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
• Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
• Evidence of "hands-on" experience and expertise
• Proven and successful track record as a team-player and collaborator in small working environments
• Highly organized and detail oriented with a passion to deliver quality results
• Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
• Highest levels of professionalism, confidence, personal values and ethical standards
• Ability to travel 20-30% as required.
The description and requirements outlined above are general; additional requirements may apply.