About the Company:
A global specialty pharmaceutical group dedicated to developing and commercialising treatments for patients with genetic, metabolic, systemic, and acute life-threatening disorders, as well as providing healthcare solutions for the general population.
About the Role: The Senior Data Manager is responsible for managing data activities for interventional and non-interventional clinical studies, ensuring compliance with applicable regulations, ICH/GCP guidelines, Standard Operating Procedures (SOPs), and study plans within assigned clinical programs.
The Senior Data Manager oversees, coordinates, and executes end-to-end data management activities from study start-up to close-out, ensuring data integrity, validity, and reliability to support study delivery according to strategy, timelines, and budgets.
Description of the Role: Senior Data Manager will:
Clinical Study Delivery:
Support the Director, Global Clinical Affairs in implementing the vision for Clinical Affairs to enhance the quality, cost, speed, and efficiency of clinical study delivery.
Maintain an overview of data management status and issues, proactively communicating progress, risks, issues, or changes to the Clinical Study Lead that may impact quality, timelines, and/or budget; provide clinical study updates as requested.
Engage cross-functionally to ensure transparency, knowledge transfer, and alignment within the study.
Key focus areas for execution and oversight include:
Supporting the Clinical Study Lead in implementing Quality by Design principles during protocol development.
Conducting start-up activities such as reviewing and developing study documentation and plans (Statistical Analysis Plan, Data Management Plan, Data Quality Review Plan), designing Case Report Forms, specifying databases, selecting and testing database software, designing and testing edit checks, and supporting risk-based quality management activities.
Overseeing study monitoring and implementing risk-based quality management processes to ensure data quality, integrity, and participant safety and rights. Ensuring data quality oversight activities align with study plans. Co-leading study-related data quality discussions, performing data review and cleaning, including query generation and resolution, and processing data from databases and external sources.
Managing database lock and transfer processes, supporting the delivery of tables, figures, and listings during study analysis.
Ensuring study files accurately reflect data management activities and documents are filed contemporaneously.
Supporting service provider selection, monitoring budgets, and managing and overseeing their activities and performance.
Ensuring inspection readiness within the studies and supporting GCP audits and inspections.
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Clinical Study Enabling Activities:
Implement and/or participate in activities and initiatives that support program and study delivery and overall portfolio efficiency, including process enhancements, digital integration of clinical trials, and knowledge transfer.
People Management:
Provide leadership, support, feedback, coaching, and mentoring to other members of the Clinical Affairs team as required.
May have direct reports within the Data Science team as agreed with the Clinical Program Lead and Director, Global Clinical Affairs.
Assist in training relevant staff as needed.
Other Responsibilities:
Support the development of external communications related to clinical studies.
Attend conferences and external events.
Conduct internal training as required.
Essential Requirements for the Role:
Bachelor's degree or equivalent experience in Mathematics, Science, or a related field.
Proven experience in the pharmaceutical or biotech industry within Clinical Research and/or Clinical Data Management.
Good knowledge of international clinical research regulations and requirements (ICH/GCP).
Experience with clinical trial databases and applications, clinical data flow, data review, and eCRF design.
Excellent written and verbal communication skills.
Strong project management skills.
Ability to lead a team effectively and work independently.
Strong observational and analytical skills.
Good time management skills and the ability to meet tight deadlines.
Ability to problem-solve and make quick decisions.
What's on Offer:
A competitive salary with benefits.
The opportunity to contribute to a team whose work directly benefits healthcare and improves people's lives.
Hands-on opportunities to gain significant commercial exposure.
The chance to work alongside world-leading scientific experts.
Collaboration with highly talented and dedicated colleagues in a fast-growing company that combines cutting-edge science with commercial delivery.
How to Apply:
Interested candidates are invited to submit their resume and a cover letter detailing their qualifications and experience.
