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Undergraduate Manager

4 months ago

Welwyn Garden City Hertfordshire, United Kingdom PHARMExcel Full time

As a senior member of our clinical operations team, you will be responsible and accountable for the operational delivery of our clinical studies, as well as ensuring compliance and adherence to timelines, budgets, and regulatory standards. You will be a self -starter, with excellent project management skills, whose drive and leadership will be instrumental in delivering our research initiatives

Lead the planning, initiation, and execution of complex clinical trials from inception to completion.
· Ensure strict compliance with regulatory requirements, GCP, and ICH guidelines.
· Lead cross-functional teams, including CRAs, data managers, biostatisticians, and other key stakeholders.
· Monitor study progress, identifying and resolving issues to maintain study integrity and data quality.
· Maintain regular communication with senior management, providing detailed reports and updates on study status.
· Vendor Management including sourcing, compliance, and collaboration
· Prepare, review, and approve study-related documentation, including protocols, informed consent forms, work instructions and regulatory submissions.
· Act as an SME to the wider clinical team and support senior clinical management team in developing new processes
·
· Bachelor's degree in a related field; MSc, PhD, MD) preferred.
· Minimum of 5-7 years of experience in clinical trial management.
· Exceptional organisational and project management skills.
· Strong leadership and team management capabilities.
· Competitive salary and comprehensive benefits package.
Opportunities to work on innovative/complex research projects.
Professional development and career advancement opportunities.

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