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Senior Clinical Trial Operations Manager
2 months ago
Position Summary:
The Senior Clinical Trial Manager will oversee and facilitate the operational planning and execution of one or more clinical trial initiatives from initial development through to regulatory endorsement. This position may entail managing both internal and external multidisciplinary teams to achieve operational goals from protocol formulation to Clinical Study Report (CSR), ensuring that all trial deliverables are accomplished in accordance with project timelines, budget constraints, and the highest quality standards (GCP / ICH, SOPs / QDs).
Key Responsibilities:
- Oversee the management and/or support of a clinical study, ensuring adherence to timelines, budgetary limits, and regulatory standards.
- Serve as the primary contact for vendors, collaborating with Clinical Research Organizations (CROs) and other third-party service providers to uphold contractual commitments.
- Maintain and report on clinical trial metrics, dashboards, and documentation to effectively communicate study progress, financials, and challenges.
- Contribute to the selection and supervision of CROs and other ancillary vendors involved in the study.
- Lead and/or manage contract negotiations and budget discussions for clinical sites; track invoices related to clinical study sites.
- Develop and/or supervise the creation of study plans and relevant clinical documents in partnership with CROs and third-party vendors, ensuring adherence throughout the study lifecycle.
- Support cross-functional team initiatives and act as a Clinical Operations expert in various activities such as data analysis, protocol deviation assessments, and process enhancements.
- Ensure compliance with good clinical practices (GCP), applicable standard operating procedures (SOP), and regulatory directives.
- Represent the organization at clinical sites and external project meetings, providing training to CRO and/or site personnel as necessary.
- Ensure alignment of cross-functional team activities with clinical development strategies.
- Manage and provide oversight for one or multiple clinical studies concurrently, demonstrating effective prioritization and time management skills.
- Review reports and assist with activities related to site selection, pre-study qualifications, initiation, routine monitoring, and study closure, ensuring compliance with company SOPs.
- Propose and implement innovative process improvements that enhance clinical trial management and cost efficiency.
- Manage and maintain clinical and regulatory documentation.
- Conduct co-monitoring visits as required.
- May supervise direct reports or mentor junior staff within the clinical operations team.
- Establish and nurture relationships with clinical trial investigators and key opinion leaders.
- Engage in additional related duties as necessary to support Clinical Operations.
Preferred Qualifications:
- A Bachelor’s degree or higher (preferably in life sciences) with a minimum of 10 years of experience in clinical research, including at least 5 years as a Clinical Trial Manager or 7 years as a Senior Clinical Trial Manager in pharmaceutical, biotechnology, or clinical site settings.
- Experience in oncology clinical trials is highly desirable.
- Familiarity with the regulatory and operational aspects of managing global oncology clinical trials, from early to late-stage.
- Ability to mentor, train, and develop junior team members.
- Strong organizational skills with the capacity to prioritize and manage multiple tasks effectively.
- Proficient in Microsoft Office Suite, electronic data capture systems, and trial management software.
- Willingness to travel up to 20%.
About OnKure:
OnKure, Inc. is a clinical-stage biopharmaceutical organization dedicated to the discovery and development of precision therapies targeting biologically validated drivers of cancers that lack effective treatment options. Utilizing a structure-based drug design platform, OnKure is building a robust pipeline of tumor-agnostic candidates. The company is actively developing OKI-219, a selective PI3KαH1047R inhibitor, as its leading program. OnKure aims to establish itself as a leader in targeting oncogenic PI3Kα and has multiple initiatives designed to address this critical oncogene.
To attract top talent, OnKure offers a comprehensive compensation and benefits package, including competitive salaries, performance-based bonuses, stock options, health insurance (medical, dental, life, and disability) for full-time employees, self-managed paid time off, and a 401(k) plan with company matching.
OnKure is an equal opportunity employer and welcomes all job applicants. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, gender identity or expression, national origin, protected veteran status, disability, or any other protected factors.
