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At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice. Clinical Trial Insurance & IBM, Manager Purpose: • Manage Clinical Trial Insurance process to globally achieve an appropriate insurance of clinical trials sponsored by BPH, Consumer Care and their affiliates, in cooperation with the Pallas AG
• Investigator Brochure (IB) Management to globally achieve an timely global availability and update of Investigator Brochures for BPH projects
• Contribute to continuous improvement of Clinical Trial Insurance and IB Management related systems and processes
• Point of contact in terms of operative Clinical Trial Insurance and IB related issues
• Trigger the central process for archiving the BPH Clinical Study Protocols in BPH's archiving system
Scope: Global
Key tasks: • Trigger timely insurance for clinical trials based on business requests by following the internal Clinical Trial Insurance processes defined
• Formal quality control of the mandatory data on clinical trials that needs to be available acc. to existing standard processes, local legal regulation, and existing insurance contracts, and trigger the Clinical Trial Insurance process accordingly
• Serve as communication link to Pallas AG, to local insurance companies, and to internal business partners for Clinical Trial Insurance related issues
• Provide regular reports on insurance issues based on business needs and requests from Pallas AG and internal business partners
• Send the Clinical Study Protocols which were received in the Clinical Trial Insurance process to the CSP Archive function, which will provide these as central point of reference
• Tracking of timely preparation and timely yearly review or updates of BPH IBs
• Storage and archiving of IBs and amendments to IBs in the central globally accessible IB database to serve as central point of reference in this matter
• Manage Bayer's IB repository database
Key relations: Position holder directly interacts with the Project/Product responsible persons of Translational Science, Clinical Development, and Global Medical Affairs, and other PHD Positions Holders up to Level 2. Interaction as well with Senior Position Holders of Development Functions of other Bayer entities (e.g., Consumer Care).
Qualifications & Competencies • Degree in Life Science, or equivalent professional experience
• Experience in clinical development related to clinical trials
• Good understanding of ICH/GCP regulations
• Understanding global legislations, regulations and guidelines
• Ability to understand different Clinical Trial Insurance requirements worldwide
• Strong written and oral communication skills, especially in English language
• Solid document management and communication management skills
• Good understanding of IT processes and databases used in Clinical Development, especially Clinical Trial Management Systems, Clinical Trial Posting System, and Document Management Systems; otherwise IT skills at user level
• Good player in global, cross functional teams
• Strength to work accurately on detail level
YOUR APPLICATION This is your opportunity to tackle the world's biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Location: Division: Enabling Functions
Reference Code: 818639
Job Segment: R&D, Medical Research, Clinical Research, Document Management, Database, Research, Healthcare, Technology
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