[Hiring] Clinical Trial Manager/Senior Clinical Trial Manager @Faeth Therapeutics

Role Description

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.

Reports to: Chief Medical Officer

Location: Remote (U.S.)

• 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.
• Participate 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.

Qualifications

• 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

• Competitive salary and equity in a well-funded, clinical-stage biotech.
• 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.