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Job Description
Structured overview of role & requirementsAbout This Role
Manage all Data Management, Coding, Clinical Data Documentation (CDD), and Data Analysis Plan (DAP) aspects for multiple medium to large clinical studies or project-level activities.
Lead functional activities and coordinate Data Managers across phase I to IV clinical trials, ensuring high-quality deliverables consistent with Good Clinical Practices and standardized data management processes.
Develop and implement scalable training models and processes; represent Data Operations during audits and inspections ensuring team-wide readiness and alignment.
Minimum Requirements
Proven experience in clinical data management and related domains including data architecture, governance, integration, quality, science, and master data.
Demonstrated strong project management skills with the ability to simultaneously manage multiple tasks and projects.
Experience with clinical data management tools and generation of data review listings for study teams.
Work Experience Required: Not explicitly mentioned in the JD.
Ideal Candidate Profile
Experienced leader capable of managing cross-cultural teams and collaborating with multiple stakeholders in global drug development environments.
Strategic thinker skilled in standardizing and documenting data management processes to improve efficiency and quality across multiple projects or programs.
Proficient communicator able to identify protocol issues affecting database design, data validation, and analysis and to effectively lead audit preparations and responses.