Lead comprehensive data management activities for multiple clinical trials, ensuring regulatory compliance and data quality.
Plan, develop, test, and validate clinical databases and EDC systems to meet trial needs.
Collaborate with clients and cross-functional teams on study design, eCRF design, and data cleaning.
Monitor and ensure data quality, accuracy, and timely database entries from study sites.
Manage external vendors to deliver quality services within project timelines.
Maintain regular communication with clients to update on milestones and progress.
Ensure adherence to GCP, ICH, and regulatory requirements, supporting audits and inspections.
Proactively track study timelines, managing risks and deviations effectively.
Contribute to process improvement by developing systems, SOPs, and guidance documents.
Support business development activities, including preparing presentations and bid defense materials.

Bachelor’s Degree in a related field
Knowledge of GCP and ICH guidelines
Experience in data review and cleaning activities
Proficiency in MS Office suite and data capture systems
Experience in clinical research, preferably with pharmaceutical or medical device companies, hospitals or CROs
Familiarity with statistics, programming, and field monitoring
Effective communication skills and leadership skills

Clinical Data Manager

Key skills