Clinical Trial Manager/Senior Clinical Trial Manager

Faeth Therapeutics•San Francisco, CA

7h•Remote

About The Position

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 their target pathway, they are advancing PIKTOR, a multi-node PI3K/AKT/mTOR inhibitor program, toward multiple near-term milestones. Faeth Therapeutics is a small, focused team where every person has direct impact, united by a shared commitment to care deeply, create boldly, and never stop learning. The company is looking for a self-motivated Clinical Trial Manager (CTM)/Sr. Clinical Trial Manager (Sr. CTM) to join their Clinical Operations team. This position is responsible for the day-to-day management of clinical trials, vendors, and clinical trial sites, working closely with cross-functional teams to ensure that clinical trials are conducted in a compliant manner aligned with organizational objectives. They 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.

Requirements

Bachelor's Degree is required
5+ years of clinical research experience within the biotech/pharma industry
Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
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.

Nice To Haves

3+ years of oncology experience preferred
Experience in a small, fast-paced start up a plus

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