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. In doing so we’re working to use food as one component of the cancer treatment protocol. Faeth’s culture emphasizes humility, collaboration, and creativity.

Faeth Therapeutics is looking for a self-motivated Clinical Trial Manager (CTM)/Sr. Clinical Trial Manager (Sr. CTM) to join our Clinical Operations team. The Clinical Trial Manager is responsible for the day to day management of clinical trials, vendors, and clinical trial sites. This position will work closely with cross-functional teams to ensure that clinical trials are conducted in a compliant manner aligned with organizational objectives. We are looking for a capable trial manager with the ability to perform and manage the duties and functions necessary to deliver a quality study on time and within budget.

This position is fully remote.

Responsibilities:

• Manage all aspects of assigned clinical trials, including, study vendor management and oversight.
• Support delivery of study milestones and ensure accurate tracking and reporting of study metrics and timelines to project teams and leadership
• Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and SOPs
• Assist in preparation and review of clinical trial documentation such as; protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, and other study level documents
• Lead site management, site engagement efforts, and coordinate streamlined site communications
• Facilitate cross-functional study team meetings and liaise with cross-functional areas for oversight of clinical study activities
• Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews
• Participates in vendor selection process as a part of outsourcing activities
• Proactively identify clinical trial issues, propose mitigations, and communicate as appropriate
• Responsible for assessing operational feasibility and contributing to operational plans
• Responsible for coordinating study-specific training of CRO study staff, monitors, investigational sites, and service providers, as appropriate
• In collaboration with legal group, facilitate the development of clinical trial related agreements and other relevant documents
• Support oversight of clinical trial budget, providing ongoing financial tracking including review of vendor invoices
• Coordinate data review process on an ongoing basis for data delivery
• Oversight of site visits including site qualification, initiation, monitoring and close-out visits, as needed
• Oversee monitoring by reviewing monitoring reports to ensure quality and resolution of site-related issues
• Ensure tracking and review of protocol deviations, including coordination to assess impact on study data
• Oversee work of junior Clinical Operations team members, as appropriate
• Support development and review of Clinical SOPs, department process improvements, and cross-functional initiatives

Requirements:

• Bachelor's Degree is required
• 5+ years of clinical research experience within the biotech/pharma industry, 3+ years of oncology experience preferred
• Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
• Experience in a small, fast-paced start up a plus
• Excellent communication skills to effectively disseminate information to project team and external partners
• Experience developing trial plans, risk assessments/mitigation, tracking trial budgets, site feasibility/selection, and clinical supplies management
• Clinical research knowledge and cross-functional understanding of clinical trial methodology
• Excellent organizational, conflict resolution, and prioritization skills
• Ability to strengthen therapeutic area knowledge and expertise through internal training and external conference attendance
• Proficient computer skills and ability to learn new platforms as needed to support trial execution and management.

Benefits:

● 100% remote work

● Health, dental, and vision

● Unlimited PTO

● Generous parental leave

● Quarterly offsites across the world with the team (when Covid permits :))

● 401K and ROTH Contribution Opportunities

● 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.