Clinical Trial Manager/Senior Clinical Trial Manager

Faeth Therapeutics is a clinical-stage oncology company listed on Nasdaq that recently raised $200M in funding. With a strong scientific foundation and a founding team that includes the discoverer of our target pathway, we are advancing PIKTOR, a multi-node PI3K/AKT/mTOR inhibitor program, toward multiple near-term milestones. We are a small, focused team where every person has direct impact — united by a shared commitment to care deeply, create boldly, and never stop learning.

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.)

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.

Working at Faeth

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

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.

All offers of employment are contingent upon satisfactory completion of a background check and verification of eligibility to work in the United States.