Responsibilities :
- Clinical data management partnerships with CROs.
- Oversee outsourced clinical data management activities from start to finish.
- Develop and standardize data handling plans and review tools.
- Collaborate with cross-functional teams for data collection and reporting.
- Ensure timelines and goals are met within budget.
- Provide updates and resolve data collection issues in study team meetings.
- Support eCRF library and database build configuration.
Requirements :
- Bachelor's degree in computer science or a related field.
- Minimum of years in clinical data management, with extensive experience in multiple indications and EDC platforms.
- At least year of management experience at a sponsor organization.
- Strong vendor management skills.
- Technical proficiency in data platforms and programming.
- Experience in clinical trial design using CDASH and SDTM standards.
- Understanding of FDA and ICH GCP guidelines.
- Experience with regulatory GCP inspections / audits.
- Proficiency in data visualization tools.
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