Clinical Research Fellow conducting clinical research in cardiothoracic surgery and cardiovascular disease at Emory University. This fellowship offers comprehensive training and mentorship in clinical research methodology.
About the role
- Senior Clinical Trial Manager at Genmab managing clinical trials and ensuring compliance with regulatory standards. Developing operational plans and coordinating with stakeholders for successful trial execution.
Responsibilities
- Develop and manage operational plans, charters, and manuals to support trial execution in compliance with regulatory and internal standards
- Review of protocol and protocol amendments
- Coordinate the development of and manage updates of the Trial Oversight Plan
- Review of the Investigator's Brochure from DevOps perspective
- Review of the Clinical Trial Application submission package
- Review of Regulatory Green Light packages
- Develop the Global Master ICF
- Act as a key liaison between internal stakeholders and CROs to oversee sponsor oversight visits and ensure quality and compliance
- Collaborate with the CRO and/or internal functions to oversee site selection based on feasibility assessments
- Monitor and manage vendor deliverables across trial operations
- Ensure ongoing accuracy and completeness of the eTMF, supporting inspection readiness and regulatory compliance
- Drive the Operational Data Base review for the trial
- Participate in inspection readiness activities, support QA in audit preparations, and conduct site visits as needed
Requirements
- Bachelor's or Master's degree with relevant specialization; Master's degree preferred
- Minimum requirement: 8+ years in clinical operations
- Significant experience leading and managing clinical trials
- Experience in leading multiple complex trials, maintenance of trial documentation, CRO engagement, and budget monitoring
- Some experience managing/guiding internal (cross-functional) and external (CRO) teams
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
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