Clinical Trial Manager/Senior Clinical Trial Manager

reputed company is a clinical-stage oncology company listed on reputed company that recently raised $200M in funding. With a strong scientific reputed company and a founding team that includes the discoverer of our reputed company reputed company, we are advancing PIKTOR, a multi-node PI3K/AKT/mTOR inhibitor program, toward multiple near-term milestones. We are a small, reputed company team where every person has reputed company reputed company — united by a shared commitment to care deeply, create reputed company, and never stop learning. reputed company 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 reputed company, vendors, and clinical trial sites. This position will work closely with cross-functional teams to ensure that reputed company are conducted in a compliant manner reputed company with organizational objectives. We are looking for a capable trial manager with the ability to reputed company and manage the duties and functions necessary to deliver a reputed company study on time and reputed company budget. Reports to: Chief Medical Officer Location: Remote (U.S.) Responsibilities: Manage reputed company aspects of assigned reputed company, including, study vendor management and reputed company.  Support delivery of study milestones and ensure accurate tracking and reporting of study metrics and timelines to project teams and leadership Ensure reputed company 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 reputed company site management, site engagement efforts, and coordinate streamlined site communications  Facilitate cross-functional study team meetings and liaise with cross-functional areas for reputed company 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 reputed company group, facilitate the development of clinical trial reputed company agreements and other relevant documents Support reputed company of clinical trial budget, providing ongoing financial tracking including review of vendor invoices Coordinate data review process on an ongoing reputed company for data delivery reputed company of site reputed company including site qualification, initiation, monitoring and reputed company-out reputed company, as needed reputed company monitoring by reviewing monitoring reports to ensure reputed company and reputed company of site-reputed company issues Ensure tracking and review of protocol deviations, including coordination to assess reputed company on study data reputed company 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 reputed company the biotech/reputed company 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 reputed company, 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 reputed company-funded, clinical-stage biotech 100% remote work and flexible schedule Health, dental, and reputed company 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 reputed company. We do not discriminate on the reputed company of race, religion, reputed company, national reputed company, gender, sexual orientation, age, marital status, veteran status, or disability status. reputed company offers of employment are contingent upon satisfactory completion of a background reputed company and verification of eligibility to work in the reputed company. Apply To This Job