FAQs
What is the primary role of a Principal Clinical Data Manager at Bayer?
The Principal Clinical Data Manager leads the execution of data management activities necessary for generating hypotheses and making decisions in research or development phases, as well as for preparing submission data for regulatory authorities.
What qualifications are required for this position?
Candidates must possess a Bachelor’s degree (or equivalent/higher) in Natural Sciences, Life Sciences, Informatics, Medical Documentation or related subjects, along with at least 7 years of experience in data management, including 2 years as a responsible DM lead on studies/projects.
What experience is necessary for this role?
At least 7 years of study and/or project-level experience in data management, with at least 2 years demonstrating full responsibility as the DM lead on studies or projects is required.
Will I be required to manage a team as a Principal Clinical Data Manager?
Yes, the Principal Clinical Data Manager will lead a Study Data Manager (SDM) team and coordinate with various extended Study Team members to ensure timely and quality data management deliverables.
What are the core competencies needed for this position?
Essential competencies include Customer Focus, Drives Results, Manages Complexity, and Plans & Aligns, along with the ability to collaborate and instill trust in a global environment.
What is the work location for this position?
The position is located in Barcelona, Catalonia, Spain.
How does the Principal Clinical Data Manager contribute to compliance?
The Principal Clinical Data Manager ensures compliance by performing duties in accordance with SOPs, GCP, ICH guidelines, and maintaining thorough documentation for all projects/studies.
Is there a focus on mentoring or training junior staff?
Yes, the Principal Clinical Data Manager is involved in mentoring junior staff and training team members in data management best practices.
What is the significance of data management in clinical trials at Bayer?
High-quality data management is crucial as it directly impacts the company's ability to make informed decisions regarding the continuation of development programs and the safety and marketability of its portfolio assets.
What methodologies and technologies should candidates be familiar with?
Significant experience with data management methodologies and technologies, such as electronic data capture and data warehousing, is preferred.
Are there opportunities for growth and development within this role?
Yes, the position offers prospects for a varied and meaningful career, allowing individuals to expand their skills and contribute to important projects in clinical research and data management.