Clinical Trial Manager
4 days ago
Overview of Role:
A highly autonomous and experienced clinical operations professional is required to manage all aspects of Clinical Trial Management for global studies. The successful candidate will be responsible for study start up and maintenance through study close out, ensuring that overall project objectives are met.
Key Responsibilities:
- Oversee study scope, quality, timelines, and budget with internal functional leads, CROs, and vendors.
- Build and maintain professional relationships with key opinion leaders and clinical site staff.
- Partner with the CRO to develop and implement patient enrollment strategies and ongoing data monitoring strategies.
- Identify and manage study-related risks.
- Develop and manage clinical trial documents, including protocols, Case Report Forms (CRFs), consent documents, and confidentiality agreements.
- Review and manage study-related plans, processes, and contracts.
- Ensure compliance with Good Clinical Practices and national and international regulatory requirements.
Requirements:
- Bachelor's degree or equivalent in a life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area.
- Minimum of 5+ years of clinical project management experience in conducting international clinical trials in a sponsor Pharma/Biotech organization.
- Prior phase II and III experience required.
- Experience with budget forecasting and management.
- Experience with clinical studies in oncology.
Benefits:
- Competitive salary range: $135,000 to $155,000 annually.
- Eligibility for bonus, stock, benefits, and/or other variable compensation.
- Health benefits, 401(k) with 6% employer match, ESPP, and flexible spending account.
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