At Roche they focus on developing medicines and diagnostics that will help patients live longer, better lives. They strive to address unmet medical needs through excellence in science – from early detection and prevention of diseases to diagnosis, treatment and treatment monitoring.
Post : Clinical Operations Study Manager
Job Description:
As the Clinical Operations Study Manager at Roche Indianapolis you are a Point of Care testing expert who is passionate about ensuring the study types planned meet US requirements and FDA approvals. You will lead the Study teams assigning and ensuring delivery of all study related tasks including keeping study monitors updated on all relevant clinical trials strategies, strategy changes and all relevant study activities and/or changes.
In this role you will:
• Be a member of the project team interfacing with R&D, Life Cycle Teams, Clinical Development Teams, Medical Affairs, Regulatory Affairs and Biometrics in the study overall design, validation and planning. Responsible for risk mitigation strategies, associated action plan and issue resolution.
• Provide Point of Care testing technical expertise
• Have responsibility for timelines, resource allocation and budget planning
• Provide oversight to outside support including CROs, consultants and/or medical advisors
Candidate Profile
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
To be successful in this role you will have a Bachelor’s Degree in Life Sciences. Advanced degree preferred.
Additionally you will have:
• Strong Point of Care testing technical expertise
• Strong technical lab expertise with demonstrated ability in assay analysis and data interpretation
• Knowledge of applicable standards and regulations for clinical trial and lab conduct
• Proven oral and written communications skills
• Proven project management, planning, organizing, and leadership skills
• Ability to work independently to make sound decisions and analyze and solve problems
• Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates
• Statistical knowledge
Additional Information:
Location: United States, Indiana, Indianapolis
Education: Bachelor’s Degree in Life Sciences
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Development
Job ID: 2732072412
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