Position Description: The (Sr) Clinical Trial Manager will drive and/or support the operational planning and activities for the implementation and conduct of one or more clinical trial projects from early development through regulatory approval. This role may be responsible for managing internal and external cross-functional teams to deliver operational objectives from protocol design through CSR, ensuring all trial deliverables are met according to the study timelines, within budget and having the highest quality standards (GCP / ICH, SOPs / QDs). Essential Duties and Responsibilities: R esponsible for management and/or support delivery of a clinical study within timelines, budget, and regulatory requirements Act as vendor lead and liaise with the Clinical Research Organization (CRO) and other third-party vendors to ensure contractual obligations are being maintained Maintain clinical trial metrics, dashboards, and documentation to communicate study status, cost, and issues Contribute to selection, oversight of CROs, and other ancillary vendors associated with the conduct of a study Drive and/or oversee contract and budget negotiation for clinical sites; manage invoice tracking for clinical study sites Develop and/or oversee development of study plans and other relevant clinical documents alongside the CRO and third-party vendor and ensure study plans are followed through the duration of clinical studies Support cross-functional team activities and serve as Clinical Operations subject matter expert in cross functional initiatives such as data review, protocol deviations review, process improvements, etc. Ensure compliance with good clinical practices (GCP), relevant standard operating procedures (SOP), and regulatory guidelines Represent the company at clinical sites and external project meetings and develop and deliver training to CRO and/or site staff as needed Ensure cross-functional team activities are aligned with clinical development plans Manage and provide adequate oversight on a clinical study or multiple studies simultaneously, with good prioritization and time management skills Reviews reports and supports activities as needed related to study center selection, pre-study qualification, initiation, routine monitoring, and close-out, and ability to complete these responsibilities in compliance with company SOPs Propose and implement innovative process ideas that impact clinical trials management and cost efficiency Manage and maintain clinical and regulatory files Perform co-monitoring visits as needed May manage direct report(s) or provide mentoring of junior staff in the clinical operations department Interact and establish relationships with clinical trial investigators and key opinion leaders Participate and perform other related duties as required to support Clinical Operations Preferred Experience and Qualifications: BS/BA or higher degree required (life sciences preferred) with at least 10 years of experience in clinical research including 5 years (CTM), 7 years (Sr. CTM) in clinical trial management in pharmaceutical, biotechnology or clinical sites Oncology clinical trial experience preferred Experience in the regulatory and operational aspects of managing global oncology clinical trials (early through late-stage trials) · Ability to mentor, train and educate junior employees Strong organizational skills, ability to prioritize and multi-task Proficiency with Microsoft Programs, electronic data capture systems, and trial management tools Travel up to 20% About OnKure: OnKure, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of precision medicines that target biologically validated drivers of cancers that are underserved by available therapies. Using a structure-based drug design platform, OnKure is building a robust pipeline of tumor-agnostic candidates. OnKure is currently developing OKI-219, a selective PI3K α H1047R inhibitor, as its lead program. OnKure aims to become a leader in targeting oncogenic PI3K α and has multiple programs designed to target of this key oncogene. To attract the very best talent, OnKure offers a generous compensation and benefits package that includes competitive pay, performance-based bonus opportunities, stock options, insurance coverage (health, dental, life, and disability) for full-time employees, self-managed paid time off, and a 401(k) plan with company match. Candidates who live in or are willing to relocate to the Boulder, CO area are preferred. The expected annual compensation range for this role, based on experience, is $140,000-$165,000. OnKure is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, protected veteran status, disability, or any other protected factors. ​​​ ​​​​​