Study Manager - Oncology

Job Description

Study Manager - Oncology

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The Study Manager applies project management, communication, and leadership skills to drive the trial's progression in compliance with all regulatory requirements.

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The main duties focus on the successful and compliant execution of the clinical trial protocol:

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• 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.
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• 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.
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• Risk and Issue Management: Leads the team in timeline management , risk identification and mitigation , and issue resolution throughout the study lifecycle.
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• 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.
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• 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.
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• Study Deliverables: Leads team efforts on key study elements, including:
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• Data management deliverables.
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• Trial-level plans and timelines.
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• Country/site selection.
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• Investigator meeting planning.
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• Communication plans.
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• Study close-out activities.
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• Vendor and Partner Management: Manages any study-specific partners and/or vendors.
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Education and Experience:

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• Required Education: Bachelor's degree (preferably in life sciences or a comparable scientific discipline).
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• Required Experience:
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• 2+ years of experience in pharmaceutical, clinical drug development, project management, and/or a medical field
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• Previous experience in Oncology is required
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Key Skills:

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• Clinical Research Knowledge: Solid knowledge of clinical research regulatory requirements, including GCP and ICH guidelines .
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• Project Management: Strong understanding and application of the principles of project planning and project management, including analytical skills for driving operational milestones.
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• 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.
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• Problem-Solving: Excellent problem-solving, prioritization, conflict resolution, and critical thinking skills.
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• Communication: Strong written and verbal communication, negotiation, and presentation skills.
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