Key Responsibilities: -
- Provide leadership across assigned trials and act as the Trial Data Manager when needed, demonstrating a business understanding of the compound profiles.
- Manage data load, transfer, and conformance of clinical trial data to NCDS compliant standards, ensuring timely and high-quality deliverables.
- Perform data management activities for study start-up, including data handling plans, data review plans, and user acceptance testing (UAT).
- Lead process and training deliverables within the platform or processes, ensuring compliance with global regulatory requirements and achieving business objectives.
- Conduct ongoing review of all data generated from clinical studies, including third-party and local lab data, and perform SAE reconciliation where applicable.
- Generate study status reports for use at clinical trial team meetings and support junior staff for assigned trials.
- Lead DAP activities for assigned project-level activities for phase I to IV clinical studies and participate in improvement initiatives and nonclinical projects.
Essential Requirements: -
- Proven experience in clinical data management, data governance, data integrity, and data quality.
- Strong project management skills with the ability to manage multiple tasks and projects simultaneously.
- Cross-cultural experience and functional breadth in managing clinical data management activities.
- Ability to recognize and resolve protocol issues that may impact database design, data validation, and analysis/reporting.
- Excellent communication and interpersonal skills to establish and maintain strong working relationships with study teams and functional lines.
- Proficiency in using data management tools to generate listings for data review and provide these to study teams.
Skills Desired
Clinical Data Management, Databases, Data Governance, Data Integrity, Data Management, Data Quality, Data Science, Waterfall Model
