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We're currently partnering with a leading international pharmaceutical company to recruit a Clinical Program Lead.
ABOUT THE ROLE
The Clinical Program Lead is responsible for activities including design, monitoring, data interpretation, and reporting related to the conduct of interventional and/or non-interventional clinical studies, in accordance with applicable regulations, ICH/GCP regulations, and Standard Operating Procedures (SOPs) within a specific assigned program.
Clinical Program delivery
* Support the Director, Global Clinical Affairs in implementing the vision for Clinical Affairs to drive quality, cost-efficiency, and speed of clinical studies.
* Implement the program strategy and contribute to the overall Clinical Affairs department strategy along with other Clinical Program Leads.
* Maintain an overview of the program status and issues; proactively communicate progress, risks, and changes that may impact quality, timelines, or budget; provide updates as needed.
* Engage cross-functionally to ensure transparency, knowledge transfer, and alignment within the program.
* Focus areas include scientific expertise, protocol development, study monitoring, data quality, safety, data management, reporting, and site and service provider management.
* Ensure inspection readiness and support GCP audits and inspections.
Clinical Program enabling activities
* Implement initiatives supporting program and study delivery, including process enhancements and digital modernization.
People Management
* Provide leadership, support, coaching, and mentoring to the Study Management Team.
* Support professional development and resource management within the Clinical Operations team.
Other Responsibilities
* Support external communication development, attend conferences, and participate in meetings with authorities.
QUALIFICATIONS/EXPERIENCE
* Graduate qualifications in Biological Sciences, Nursing, Pharmacy, or Medicine (post-graduate desirable).
* Knowledge of international clinical research regulations, ICH/GCP guidelines.
* Proven experience managing clinical trials and programs in the EU.
* Knowledge of data management, excellent communication, project management, leadership, and analytical skills.
WHAT'S ON OFFER
* Competitive salary with benefits.
* Opportunity to contribute to healthcare improvements and gain commercial exposure.
* Work alongside scientific experts in a fast-growing company.
Interested in making a difference? Apply now or contact us to learn more about this exciting opportunity! #J-18808-Ljbffr