Senior Manager, Data Science
4 days ago
The Senior Data Manager will oversee data management activities for interventional and non-interventional clinical studies, ensuring compliance with applicable regulations, ICH/GCP guidelines, Standard Operating Procedures (SOPs), and study plans across assigned clinical programs.
This role is crucial in managing end-to-end data management activities from study initiation to closeout, maintaining a focus on data integrity, validity, and reliability to support study delivery according to strategic timelines and budgets.
Responsibilities- Support the Director of Global Clinical Affairs in implementing a vision for Clinical Affairs that enhances the quality, cost, speed, and efficiency of clinical study delivery.
- Maintain oversight of data management status and proactively communicate progress, risks, issues, or changes that may affect quality, timelines, or budget to the Clinical Study Lead.
- Assist in implementing Quality by Design principles during protocol development.
- Oversee study monitoring and implement risk-based quality management processes to ensure data quality, integrity, and participant safety.
- Manage database lock and transfer processes and support the delivery of tables, figures, and listings.
- Ensure study files accurately reflect data management activities and that documents are filed contemporaneously.
- Support selection and oversight of service providers, monitoring budgets, and managing performance.
- Ensure inspection readiness for studies and support GCP audits and inspections.
- Engage in initiatives that enhance the efficiency of programs and studies, including process improvements, digital integration, and knowledge transfer.
- Provide leadership, support, feedback, coaching, and mentoring to members of the Clinical Affairs team.
- May supervise direct reports within the Data Science team, as agreed with the Clinical Program Lead and Director of Global Clinical Affairs.
- Assist in training relevant staff as necessary.
- Conduct internal training sessions when required.
- Bachelor's degree or equivalent experience in Mathematics, Science, or a related field.
- Proven experience in the pharmaceutical or biotech industry, specifically in Clinical Research and/or Clinical Data Management.
- Experience with clinical trial databases, data flow management, and eCRF design.
- Strong project management abilities.
- Competitive salary with benefits.
- Hands-on experience with high commercial exposure.
- Collaboration with world-leading scientific experts.
- A chance to work with dedicated colleagues in a fast-growing company focused on cutting-edge science and commercial success.
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