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You will be updated with latest job alerts via emailAt Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
A healthier future. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. Thats what makes us Roche.
We are looking for a dynamic and experienced Global Study Lead to join our team. In this pivotal role you will lead global study teams to ensure the successful of clinical studies. You will be responsible for delivering highquality study designs adhering to timelines and budgets and collaborating with crossfunctional teams to support evidence generation strategies.
If you have a passion for advancing clinical trials in the cardiovascular/metabolic area specifically in Near Patient Care 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 realworld evidence) and ensure crossfunctional cooperation with Regulatory Affairs R&D 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 studylevel budget of assigned studies.
Ensure compliance with regulations guidelines and standard operating procedures while ensuring audit/inspection readiness.
Oversee of sponsored studies for registrational and nonregistrational purposes through all study phases (planning startup conduct and closeout).
Manage study activities outsourced to service providers including CROs ensuring timely and quality .
Work with the Publication Team to ensure study results are effectively published.
Track project performance and ensure that projects are completed on time within scope and within budget.
Build and maintain strong collaborative relationships with internal and external stakeholders including crossfunctional teams CROs opinion leaders investigators and key customers.
Your Profile:
Strong experience in clinical trial management particularly in the cardiovascular/metabolic indication and Near Patient Care. Experience with studies in an emergency department setting is a plus.
You have a degree in Life Sciences Healthcare or a related field. A background in multiple disease areas is a plus.
You have 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.
Youre able to explain difficult or sensitive information and build consensus among stakeholders.
You have a proven ability to build and maintain relationships with internal teams external partners and key stakeholders including CROs and international opinion leaders.
You are able to be onsite at our Scotland LumiraDx site Stirling roughly 23 days per week.
If youre 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.
Please upload only your current compelling CV and / or Cover Letter. We look forward to receiving your application!
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver lifechanging healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Exec
Full-Time