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 leading global clinical trial activities at Galderma. Collaborating with cross-functional teams to ensure compliance with regulatory requirements and manage clinical trial progress.
Responsibilities
- Plan and manage overall activities for assigned global clinical trial(s)
- Lead and manage cross-functional Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices
- Work closely with the Clinical Science Experts and Clinical Scientist for the design of the clinical trials
- Establish project milestones, budget and timelines for the study in partnership with the Clinical Trial Team and outsourcing manager
- Manage clinical trial progress and ensure completeness of documentation and data collection in adherence with the project timelines
- Proactively identify potential risks and develop & implement action plans to avoid or mitigate program risks
- Contribute to the reporting of clinical studies and clinical documentation to regulatory submissions according to plan and in compliance with applicable regulatory requirements, international standards and the company quality system throughout the development life cycle
- Manage Contract Research Organizations (CROs) and Functional Service Providers (FSPs)
- Collaborate with Procurement to prepare clinical outsourcing specifications
- Serve as the primary trial contact with the CRO and FSPs
Requirements
- University degree required in Life Sciences such as biology, pharmacology, nursing, or health sciences
- Progressive experience in clinical research/operations (at least 5 years)
- Experience from all parts of the clinical trial process, from protocol development to the compilation of study reports
- Experience as manager of clinical trials in major market(s) such as US, China
- Experience in supervising CROs.
- Excellent understanding of the drug development process, systemic drug and biologics experience preferred
- Excellent knowledge of international ICH/GCP guidelines, basic knowledge of GMP/GDP
- Excellent knowledge of relevant local regulations
- Fluent in English (written and oral)
Benefits
- Health insurance
- 401(k) plan with employer match
- Generous paid time off policy
- Hybrid work schedules
- Opportunity to participate in an annual short-term incentive program
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