Manager of Clinical Trial Insurance

hace 4 semanas

Barcelona, Barcelona, España Bayer A tiempo completo

At Bayer, we are innovators committed to addressing the world's most pressing challenges, striving for a reality where 'Health for all, Hunger for none' is achievable. Our journey is fueled by energy, curiosity, and unwavering dedication, as we learn from diverse perspectives, broaden our horizons, enhance our skills, and redefine what is possible. There are countless reasons to become part of our team. If you are eager to cultivate a diverse and impactful career among brilliant minds, Bayer is the place for you.

Position: Clinical Trial Insurance Manager

Objective:


• Oversee the Clinical Trial Insurance process to ensure appropriate coverage for clinical trials sponsored by BPH, Consumer Care, and their affiliates, in collaboration with Pallas AG.

• Manage the Investigator Brochure (IB) to ensure timely global availability and updates for BPH projects.

• Drive continuous enhancements in Clinical Trial Insurance and IB Management systems and processes.

• Serve as the primary contact for operational Clinical Trial Insurance and IB-related inquiries.

• Initiate the central process for archiving BPH Clinical Study Protocols within BPH's archiving system.

Scope: Global

Key Responsibilities:


• Initiate timely insurance for clinical trials based on business requests, adhering to established Clinical Trial Insurance processes.

• Conduct formal quality control of mandatory data related to clinical trials, ensuring compliance with standard processes, local regulations, and existing insurance contracts, and trigger the Clinical Trial Insurance process as necessary.

• Act as a communication liaison with Pallas AG, local insurance providers, and internal business partners regarding Clinical Trial Insurance matters.

• Generate regular reports on insurance-related issues based on business needs and requests from Pallas AG and internal stakeholders.

• Forward Clinical Study Protocols received during the Clinical Trial Insurance process to the CSP Archive function for centralized reference.

• Monitor the timely preparation and annual review or updates of BPH IBs.

• Ensure proper storage and archiving of IBs and amendments in a globally accessible IB database for centralized reference.

• Manage Bayer's IB repository database.

Key Relationships:

The position holder will directly engage with Project/Product leaders in Translational Science, Clinical Development, and Global Medical Affairs, as well as other PHD Position Holders up to Level 2. Interaction will also occur with Senior Position Holders from Development Functions across other Bayer entities (e.g., Consumer Care).

Qualifications & Skills:


• Degree in Life Sciences or equivalent professional experience.

• Proven experience in clinical development related to clinical trials.

• Strong understanding of ICH/GCP regulations.

• Familiarity with global legislation, regulations, and guidelines.

• Ability to comprehend diverse Clinical Trial Insurance requirements across different regions.

• Excellent written and verbal communication skills, particularly in English.

• Solid document and communication management capabilities.

• Proficient understanding of IT processes and databases utilized in Clinical Development, particularly Clinical Trial Management Systems, Clinical Trial Posting Systems, and Document Management Systems; otherwise, IT skills at a user level.

• Collaborative team player in global, cross-functional teams.

• Attention to detail and accuracy in work.

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