open positions

Senior Clinical Data Manager / Clinical Data Manager

Location: Somerville, Massachusetts, 02143, United States
Full-time

About Finch  

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. 

 

Position Summary 

The { Senior } Clinical Data Manager is primarily accountable for the acquisition, transit, cleaning and overall quality of clinical study data. S/he must be able to interact collaboratively with cross-functional teams and oversee data management actitives at CROs.

 

Responsibilities 

Reporting to the Senior Director of Biometrics, the { Senior } Clinical Data Manager provides oversight for data management projects. 

  • Manages data activities for all clinical trials, as well as the design, review, and validation of the clinical database to deliver data for analysis and submission as part of a regulatory filing. 
  • Designs/reviews case report forms (CRFs) as well as data edit checks and aggregate check specifications with the CRO. 
  • Oversees the development of any clinical database by the EDC/CRO vendor and will manage the sponsor user acceptance testing of the clinical database. 
  • Works in coordination with statisticians and programmer/analysts. 
  • Works in coordination with clinical research and development, clinical operations, and CROs to develop study documents including the study protocols, (CRFs), and CRF instructions. 
  • Primary interface with CROs for any data management related activities. 
  • Ensures that data management tasks remain on target according to study timelines and requirements. 
  • Proactively works with CROs to organize on-going data review throughout the study to ensure timely identification and correction of errors or discrepancies.  
  • Routinely communicates site data concerns/issues with clinical operations team and CROs in order to ensure collaboration toward resolution. 
  • Ensures delivery of a quality locked database for analysis at the close of studies. 

 

Qualifications  

  • 3+ years of clinical trial data management experience, preferably in biopharma or medical device industry
  • Experience with clinical databases such as Medrio, MedidataRAVE, Clindata, Oracle
  • Strong understanding of clinical trial process and EDC platforms
  • Experience with data programming tools and/or data viewing tools (J-review, SAS, JMP, etc.) 
  • Excellent communication and organizational skills, along with problem solving, conflict resolution, leadership and team-building skills

 

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. 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.