Faeth Therapeutics is a biotech start-up founded in 2019 by an international group of world-leading cancer research scientists. Faeth’s mission is to use a deep mechanistic understanding of cancer metabolism to rethink the treatment of cancer. Faeth’s culture emphasizes humility, collaboration, and creativity.

We are looking for a highly self-motivated Clinical Data Manager to join our team. The Clinical Data Manager will play a pivotal role in providing end-to-end data management activities. This position will be responsible for delivery on clinical databases, execution of clinical data deliverables and providing data management expertise to the team. It is expected that this person is detail oriented while also being action oriented. This is a unique opportunity to join our early team and pioneer the discovery of a new generation of therapeutic interventions for cancer.

Responsibilities:

• Lead end-to-end clinical data management activities within the study team and represents data management on internal and external cross functional teams
• Lead and oversee vendors in data management activities including database build, data review, and database lock, following requirements defined in the clinical protocol and in alignment with industry best practice guidelines and data standards and processes
• Draft, review and finalize data management documents, coordinating input with the clinical study team including but not limited to the Data Management Plan, eCRF specifications, eCRF Completion Guidelines, Coding Guidelines, Data Transfer Specifications, and Data Review Plans.
• Coordinate coding schedule and coding review to fulfill reporting requirements
• Perform Query Quality Control for vendor performance and data quality oversight; reviews clinical data to ensure data collection is of high quality and completed per protocol specifications
• Collaborate with cross-functional team members on achieving overall clinical development milestones and timelines including dose review meetings, abstracts/publications, internal/external meetings, and interim/primary analyses
• Contribute to/participate in data management initiatives and innovation by supporting development of data management procedures and contributing to non-project initiatives

Requirements:

• Bachelor's degree and 4-6 years of experience in clinical data management
• Experience in oncology drug development across different study phases
• Strong experience of EDC systems
• Successful experience managing vendor relationships
• Strong knowledge of FDA and ICH/GCP regulations and industry standards applicable to data capture and overall data management process
• Effective oral and written communication skills; excellent interpersonal skills
• Attention to detail and commitment to high quality and on-time deliverables
• Ability to prioritize and handle multiple tasks simultaneously and strong organizational skills
• Team oriented and collaborative

Benefits:

• Competitive salary and meaningful equity in a well-funded, early stage startup
• 100% remote work and flexible schedule
• Health, dental, and vision for you and your dependents
• Flexible time off
• Generous parental leave
• Traditional and Roth 401k
• Mission oriented, remote first culture

Faeth was founded in 2019 by Siddhartha Mukherjee, oncologist and Pulitzer Prize winning author, Karen Vousden, Chief Scientist of CRUK & Lew Cantley, Director of the Meyer Cancer Center at Weill Cornell among others. Faeth’s investors include Khosla Ventures, Future Ventures, Digitalis and many more.

We are an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.