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Clinical Data Management Professional
2 months ago
About the Role
We are seeking experienced Clinical Data Managers to contribute to our team and support a leading pharmaceutical company. As a Clinical Data Manager, you will play a vital role in ensuring the quality and integrity of clinical trial data from study initiation to completion.
Your Responsibilities
- Provide expert guidance and leadership within the Clinical Trial Team, contributing your knowledge and experience to all aspects of data management.
- Lead in the setup phase of clinical trials, including eCRF configuration, User Acceptance Testing (UAT), development of study plans and documentation, and strategic meetings with the study team.
- Manage data validation processes, address queries effectively, review data reports, implement corrective actions, and oversee third-party data loading and reconciliation.
- Coordinate data review meetings and database lock procedures, ensuring adherence to regulatory guidelines and best practices.
- Maintain a strong working relationship with external vendors, monitoring their performance and implementing mitigation strategies as needed.
Your Qualifications
- A Bachelor's, Master's, or PhD degree in life sciences, mathematics, or a related field.
- Proven experience in Clinical Data Management, with a minimum of 1-3 years for Junior roles, 5-8 years for Manager roles, and extensive experience for Senior Manager roles.
- A strong understanding of Clinical Trial Development Processes and ICH-GCP guidelines.
- Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams.
- Proficiency in clinical study management tools and systems, including the ability to manage multiple external data systems.
- Mastery of Microsoft Office Suite.
- Fluency in English (written and spoken).
