Clinical Trial Insurance Manager

hace 2 semanas

Barcelona, Barcelona, España Bayer A tiempo completo

At Bayer, we're driven to solve the world's toughest challenges and strive for a world where health for all and hunger for none is no longer a dream, but a real possibility.

Clinical Trial Insurance & IBM, Manager

Purpose:

Manage the Clinical Trial Insurance process to achieve global insurance of clinical trials sponsored by BPH, Consumer Care, and their affiliates in cooperation with Pallas AG. Investigator Brochure (IB) Management involves achieving timely global availability and updates of IBs for BPH projects. Contribute to continuous improvement of Clinical Trial Insurance and IB Management related systems and processes. Serve as the point of contact for operative Clinical Trial Insurance and IB related issues. Trigger the central process for archiving 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 internal Clinical Trial Insurance processes.

Perform formal quality control of mandatory data on clinical trials, ensuring compliance with existing standard processes, local legal regulations, and existing insurance contracts. Trigger the Clinical Trial Insurance process accordingly.

Serve as a communication link to Pallas AG, local insurance companies, and 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 Clinical Study Protocols received in the Clinical Trial Insurance process to the CSP Archive function, which will provide these as a central point of reference.

Track timely preparation and timely yearly review or updates of BPH IBs.

Store and archive IBs and amendments to IBs in the central globally accessible IB database to serve as a central point of reference.

Manage Bayer's IB repository database.

Key relations:

Position holder directly interacts with Project/Product responsible persons of Translational Science, Clinical Development, and Global Medical Affairs, and other PHD Positions Holders up to Level 2. Interaction also 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.

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