Global Study Lead – Cardiovascular/Metabolic Disease
We are looking for a dynamic and experienced Global Study Lead to join our Clinical Development & Medical Affairs team. In this pivotal role, you will lead global study teams to ensure the successful execution of clinical studies.
If you have a passion for advancing clinical trials in the cardiovascular/metabolic disease area (CVMD), specifically in Core Lab SWA (Serum Work Area) Systems and Automation, we would love to hear from you.
Key Responsibilities
- Lead and oversee the global study team, ensuring full accountability for study deliverables including quality, budget, and timelines.
- Collaborate with Program Leadership to prepare different scenarios for evidence generation (e.g., study, real‑world evidence) and ensure cross‑functional cooperation with Regulatory Affairs, R&D, Biostatistics, Data Management and CDMA Project Teams.
- Develop key study documents such as Design Validation Plans, study protocols, training materials, study forms, templates, and study reports.
- Maintain responsibility for the study‑level budget of assigned studies.
- Ensure compliance with regulations, guidelines, and standard operating procedures, while ensuring audit/inspection readiness.
- Oversee execution of sponsored studies for registrational and non‑registrational purposes through all study phases (planning, start‑up, conduct, and close‑out).
- Manage study activities outsourced to service providers, including CROs, ensuring timely and quality execution.
- Work with the Publication Team to ensure study results are effectively published.
- Track project performance and ensure projects are completed on time, within scope, and within budget.
- Build and maintain strong, collaborative relationships with internal and external stakeholders, including cross‑functional teams, CROs, opinion leaders, investigators, and key customers.
Qualifications
- Strong experience in clinical trial management, particularly in cardiovascular/metabolic indications.
- Experience with IVD clinical and analytical system studies in the Core Lab Serum Work Area setting is a plus.
- Degree in Life Sciences, Healthcare, or a related field.
- Background in multiple disease areas is a plus.
- Practical knowledge of clinical trial management and product development with a solid understanding of Clinical Operations.
- Ability to lead and manage projects and provide guidance to less experienced colleagues.
- Strong analytical skills to solve complex problems and provide innovative solutions.
- Excellent communication skills to explain difficult or sensitive information and build consensus among stakeholders.
- Proven ability to build and maintain relationships with internal teams, external partners, CROs, and international opinion leaders.
Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care.
If you’re looking to make a significant impact in a leading global healthcare organisation and have the required experience and qualifications, we invite you to apply today.
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