Clinical Project Manager
Location: Somerville, Massachusetts, 02143, United States
Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery platform to develop a novel class of orally administered biological drugs.
With the capabilities to develop both complete and targeted microbiome therapeutics, Finch is advancing a rich pipeline of candidates designed to address a wide range of unmet medical needs. Finch’s lead candidate, CP101, is in late-stage clinical development for recurrent C. difficile infection (CDI). In June 2020, Finch announced that CP101 met its primary efficacy endpoint in PRISM3, the first of two pivotal trials to support the development of CP101 for the prevention of recurrent CDI. Finch is also developing CP101 for chronic hepatitis B, and FIN-211 for autism spectrum disorder. In partnership with Takeda, Finch is advancing FIN-524 and FIN-525 for ulcerative colitis and Crohn’s disease, respectively.
Manages clinical project team members to appropriate and timely completion of projects; oversees project timeline development and maintenance. Internally interfaces with data management and biostatistics, regulatory affairs, clinical compliance, medical directors, and vendors. Understands corporate goals and project objectives. The successful candidate will be responsible for independently managing a small number of studies of basic to moderate complexity or defined activities in more complex, multicenter studies (e.g., managing niche vendors). The Clinical Project Manager will be able to organize and manage multiple tasks related to clinical studies under supervision, while simultaneously ensuring study timelines and milestones are met and studies completed according to the protocol.
This position will report into the Senior Director of Clinical Operations.
- Manage day to day operations of assigned studies.
- Coordinate activities of associates, vendors and investigators to ensure compliance with protocol and overall clinical objectives.
- Manage projects to achieve goals on schedule.
- Participate in the design and planning of clinical research projects.
- Participate in or lead clinical project team meetings.
- Participate in or lead cross functional team meetings to strategically move project forward.
- Provides input to development of clinical documents.
- Develop and maintain study timelines for assigned studies with minimal supervision.
- Implement and track project timelines, and project specific plans, including, but not limited to: project plans, monitoring plans.
- Participate in vendor selection process, including RFP generation, review of proposals, and capability presentations.
- Oversee vendor execution of clinical monitoring from site qualification to site closure visits and assures integrity of clinical data with respect to accuracy, accountability and documentation through review of monitoring reports, case report forms, source documents and medical records.
- Work closely with CRO management in overseeing CRO activities and tracking of metrics/study progress.
- Work with Data Management to assure quality and timeliness of data analysis and transfers.
- Evaluate the probability and impact of risks on project objectives. Develop risk mitigation plans with project teams.
- Apply thorough knowledge of GCP/regulatory requirements to all aspects of study preparation and oversight.
- Ensures study metrics are tracked and on target.
- Contribute to timelines in appropriate areas for cross functional departments.
- Participate in development and review of clinical study budgets, including site and vendor budgets; contribute to monitoring of study expenditures and payments, including accruals.
- Manages studies within budget.
- Review and approve invoices for study payments to sites and vendors.
- Provide input for accurate budget forecasts, including input for Long Range Plan.
- Review documentation for assigned trials ensuring it is completed in accordance with internal SOP’s and GCP requirements (e.g., Patient Informed Consent Forms, Monitoring Plans, Project Plans and consistent with the study protocol).
- Review safety reports and participate in safety review activities.
- Provide substantive input into data/listing/TLF reviews.
- Responsible for assuring quality of key study team deliverables, including protocols, and study plans.
- Provide substantive input into CSRs and relevant sections regulatory submissions, including pre-IND briefing documents, INDs, NDAs.
- Provide substantive input into review and preparation of CRFs, data plan and SAP.
- Maintain a high level of professional expertise through familiarity with clinical literature.
- Demonstrate technical expertise with an in-depth knowledge of drug development, including working knowledge of Finch clinical systems.
- Participate in and coordinates internal and external therapeutic training for project team members.
- Understand unique requirements of conducting studies in unmet medical need, novel treatment environment.
- Bachelor’s Degree (B.S. preferred), applicable to the health sciences field.
- 6+ years of experience in clinical development.
- Computer skills: Proficient with Microsoft Office.
- Strong knowledge of GCP/ICH and FDA regulatory requirements and excellent organizational ability
- Excellent oral and written communication skills with strong business acumen
- Strong knowledge of clinical drug development process, clinical study design and planning. Requires proven time management, project management skills and leadership ability.
- Builds productive working relationships internally and externally.
- Works under general direction.
- Represents functional area in providing solutions to difficult technical/functional issues associated with specific projects.
- Passion, humility, and excitement for doing whatever it takes to drive research forward toward a goal of helping patients with unmet medical needs.
More About Finch
Here at Finch, we strive to create the best work environment and experience for you through our formal benefits programs and fringe perks. Together, we hope that we’ll create a fun & supportive environment in and out of the workplace as we strive to create a new class of therapeutics together to help patients.
- Our formal benefits include medical, dental, and vision coverage through Harvard Pilgrim in addition to life insurance and long-term & short-term disability policies. We offer discretionary and flexible paid time off policies. Should you choose to start or grow your family while working at Finch, we aspire to lead our peers by offering several months of paid parental leave. We also offer a generous non-discretionary 401K contribution to help teammates save for life beyond Finch in the future and other savings and investment opportunities.
- We also try to keep the workplace an inspiring and motivating place to work with our fringe perks. Our facilities in Somerville, MA include an in-office gym with a shower and towel service (temporarily closed due to COVID), fully stocked kitchen with free snacks, iced coffee & flavored/sparkling waters on tap, and highly subsidized meals through LeanBox. We sponsor ride-sharing to and from the office from preset locations around Boston, Cambridge, and Somerville. We are always evaluating our fringe perks and hope to grow them alongside our team.
*Only facility-dependent employees are working on-site in Somerville until further notice.
Equal Opportunity Employer
We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. Finch will make reasonable accommodations for qualified individuals with disabilities, in accordance with applicable law.