Global Study Area Lead

Roche • Indianapolis, IN

1d

About The Position

A healthier future. It’s 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. That’s what makes us Roche. The Global Study Area Lead is a strategic leader within clinical operations and is responsible for providing strategic direction to clinical operations portfolio, infrastructure or clinical programs to deliver the clinical trial portfolio in line with clinical development plans. Anticipates new trends in innovative technology solutions, processes, therapeutic or disease area landscape and develops novel approaches to deliver the clinical operations portfolio. Partners with stakeholders across the enterprise and external partners to ensure development and delivery of the clinical portfolio or develop innovative technology solutions. Identify, develop and implement innovative solutions to enhance the delivery of clinical trials and impact clinical trials management. May manage clinical operational plans including project planning, budget and resource management and CRO management. May develop study related documents and overall direction for the clinical sites. Ensures compliance with good clinical practices and regulatory guidelines. Effectively leads in the matrix: provides direction to teams, oversees coaches and develops clinical trial staff to ensure efficient operation of the function.

Requirements

• You have a Bachelor's degree in Life Sciences
• You have 10+ years of experience in execution of sponsored studies for assigned areas of focus for registrational and/or non-registrational purposes through all study phases (planning, start-up. conduct and close-out). Oversees study activities outsourced to a service provider (i.e., CRO).
• You have extensive experience in ensuring that study results are published in collaboration with the Publication Team.
• You have 6+ years of experience overseeing projects to ensure completion on-time, within scope and budget; and track project performance to analyze the completion of short and long term goals.
• You are recognized as an expert on Product Development. Has in-depth and/or broad expertise in Product Development generally and Clinical Operations specifically or related areas.
• You are able to anticipate organization and industry issues and recommend research, products, processes and/or services improvements.
• You have the ability to lead programs, projects or initiatives with notable risk and complexity across areas of expertise
• You have prior experience building and maintaining strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders and other alliance partners, including CROs, in meeting business goals and ensuring operational excellence.

Nice To Haves

• Advanced Degree in Life Sciences

Responsibilities

• Lead on a matrix environment the Global Study Leads, providing strategic direction to the portfolio of indication areas assigned, with full accountability for the study management deliverables concerning quality, budget and timelines.
• Ensures the development of high quality study designs for sponsored studies in collaboration with internal and external experts
• In collaboration with Program Leadership, prepares different scenarios for evidence generation (e.g. study, real-world evidence) in cross-functional collaboration (e.g. with Regulatory Affairs, R&D, CDMA Project Teams) to support global strategies and planning of timeline and costs
• Develop (and provides technical expertise to Global Study Leads) of key study documents (i.e., product development plans, protocol, study training materials, study forms and templates, study report)
• Oversee planning and operational aspects of Investigator Initiated Studies, Testing Access Readiness Program & Early Adopter Programs (TARPs) and Research Collaborations, impacting larger organizational goals
• Oversee planning and operational aspects of companion diagnostics studies sponsored by Pharma partners, impacting larger organizational goals
• Act as a coach for colleagues with less experience and help them develop skills/expertise.
• Support SMa Sub-Chapter Leads/ Team Leads with best practices, harmonization efforts, onboarding of newcomers, inspection readiness and resources allocation
• Accountable for the oversight of study-area level budget of allocated study areas.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level