Study Manager - Oncology

Posted 3 days ago

kelly science engineering technology telecomDenver (CO)

Clinical Research Coordinators Research and Development in Biotechnology (except Nanobiotechnology)

SENIORITY

Manager

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About the role

Study Manager - Oncology The Study Manager applies project management, communication, and leadership skills to drive the trial's progression in compliance with all regulatory requirements. The main duties focus on the successful and compliant execution of the clinical trial protocol: Operational Planning and Execution: Accountable for the end-to-end performance of assigned protocols. This includes proactive planning, driving, and tracking deliverables, timelines, and results from study startup through closeout. Team Leadership & Coordination: May serve as the Clinical Trial Team (CTT) lead or coordinate local study teams (including CRAs and other local roles), ensuring strong collaboration and high performance. Risk and Issue Management: Leads the team in timeline management, risk identification and mitigation, and issue resolution throughout the study lifecycle. Stakeholder Collaboration: Facilitates and collaborates with key internal and external stakeholders, such as the study team, country teams, functional vendors, and investigators/sites, to support study objectives. Regulatory Compliance and Quality: Ensures study execution is in compliance with ICH/GCP (Good Clinical Practice) and country-specific regulations, company policies, and quality standards. Study Deliverables: Leads team efforts on key study elements, including: Data management deliverables. Trial-level plans and timelines. Country/site selection. Investigator meeting planning. Communication plans. Study close-out activities. Vendor and Partner Management: Manages any study-specific partners and/or vendors.

Education and Experience

Required Education: Bachelor's degree (preferably in life sciences or a comparable scientific discipline).

Required Experience: 2+ years of experience in pharmaceutical, clinical drug development, project management, and/or a medical field Previous experience in Oncology is required

Key Skills: Clinical Research Knowledge: Solid knowledge of clinical research regulatory requirements, including GCP and ICH guidelines. Project Management: Strong understanding and application of the principles of project planning and project management, including analytical skills for driving operational milestones. Leadership and Influence: Ability to apply leadership skills in a matrix environment, proactively driving toward study goals and influencing peers, internal/external customers, and vendors. Problem-Solving: Excellent problem-solving, prioritization, conflict resolution, and critical thinking skills. Communication: Strong written and verbal communication, negotiation, and presentation skills.

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