Clinical Operations Expert
Ever feel burnt out by bureaucracy? Us too. That’s why we’re changing the way we work— for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here https://www.bayer.com/en/strategy/strategy

TASKS AND RESPONSIBILITIES

STUDY START-UP & SUPPORT:

• Execute study start-up activities in collaboration with local team including, e.g.: a. Execute CDA b. Ensure local translations completed c. Compile and distribute ISF documents d. Manage greenlight process e. Conduct debarment checks f. Support site activation planning (i.e. potential sites for early activation).
• Conduct local document quality checks.
• Coordinate provision/return/destruction of study supplies (e.g. PRR materials, Kits4Life, kits, etc.).
• Maintain study-relevant systems (incl. Gemstone, vendor systems and tools). Ensuring data and document completeness and quality at the site and country level.
• Complete relevant post-site closeout visit activities (e.g. ensure provision of EOSPDF, treatment allocation, related tasks).

QUALITY:

• Proactively identify and communicate issues, taking appropriate action to prevent recurrence of identified deviations.
• Ensure timely and comprehensive resolution of issues that may affect compliance or the quality of study related activities or data.
• Contribute to the preparation, conduct, and follow-up of Site Audits and Regulatory Inspections to ensure a successful outcome.

WHO YOU ARE

• Bachelor's degree or equivalent or have a combination of education.
• Clinical operations experience is required.
• Effective written and verbal English communication skills, advanced level.
• Oral presentation & interpersonal skills.
• Awareness & understanding of cultural and regional differences.
• Planning and organization, time management, prioritization.
• Be able to work independently; have critical thinking and issue resolution.
• Thrives in ambiguous and collaborative environments and embraces change.
• Willingness to travel when business requires (e.g. office meetings, study meetings, local and/or international level).

WHAT WE OFFER YOU

• Hybrid Working Style.
• Full-time employment contract.
• Attractive benefits package.

At Bayer we believe in diversity, equity and inclusion. We aim to create an environment in which everybody can feel authentic, respected and equally valued. Every day we strive to reflect our values through our people unique capabilities, self-experiences, and aspirations. We, intentionally seek diversity, to enable our people bring their fullest potential out and encourage others to likewise do so. Our company wins, when we leverage our capabilities to lead the cultural transformation in our business, positively impacting the society.

Candidates who meet the requirements based on the job profile will be considered for employment regardless of physical disability, race, color, religion, sex, age, sexual orientation, gender identity and will not be at a disadvantage if unemployed.