Reports to: Head of Clinical Operations
Position Summary
The Associate Clinical Trial Manager leads the developing team of Clinical Research Associates to oversee the successful execution of Fractyl’s Remain clinical study, ensuring accuracy, quality and compliance with regulatory requirements and protocol designs. Collaborating closely with cross functional teams, the leader oversees the timely delivery of study milestones through effective planning, organization, and tracking of the clinical monitoring process; administration of clinical trials; training of site staff; study close out activities; and others as necessary.
Primary Responsibilities
- Manage the CRA team’s deliverables
- Mentor CRAs to understand the role and responsibilities as well as the study protocol
- Oversee proper study monitoring requirements, inclusive of adherence to monitoring SOPs, monitoring plans, GCP guidelines, regional regulations, and quality and risk-based effectiveness
- Working with the CRA team, manage site trends and metrics through dashboard review and ongoing risk assessments to ensure quality standards
- Guide in the development of important study documents
- Lead and implement improvements to optimize effectiveness and efficiencies within the team
- Oversee and ensure successful relationships with clinical sites, addressing issues escalated by study teams
- Oversee and coordinate adequate site monitoring allocations, training, visit schedules and reports
- Develop and implement CRA training plan, tracking training metrics and reports
- Attend and/or support co-monitoring visits as needed, evaluating the CRAs deliverables and ensuring success
- Attend and/or support Investigator/Site identification and meetings as needed
- Design, develop and provide monitoring plans, reports, processes and playbooks
- Develop SEV, SIV and other site trainings and presentations
- Support site audits/inspections as needed, and follow through with findings to resolution
- Working with Oversight Monitor, develop tools and processes for conduct of Quality Evaluation visits
- Perform all activities in compliance with applicable regulations, Fractyl’s policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training
- Bring a “can do” spirit to work and deliver on other responsibilities as assigned
Education or Certification Requirements
- Bachelors or Masters degree in any Science related field
Professional Work Experience
- Requires greater than 4 years clinical research experience including project management experience or equivalent combination of education, training and experience
- Thorough understanding of clinical study process and execution with extensive knowledge of ICH-GCP
- Strong knowledge of clinical trial regulations (US FDA, EMEA, etc.)
- Hands-on experience in managing and mentoring teams
- Experience in biotech, pharmaceutical and/or medical device industries preferred.
- Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).
Qualifications and Skills
- Highly effective interpersonal skills
- Solid problem solving and analytical skills
- Ability to handle large and complex trials
- Working knowledge of clinical study conduct inclusive of successful track record of timely cross-functional communication
Other Essentials and Key Success Factors
- Successful track record of working in high-growth and dynamic organizations
- 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
Travel
- This position requires up to 30% travel, when needed.
The description and requirements outlined above are general; additionalrequirements may apply.
