Data Management Leader
hace 2 semanas
About the Role
The Senior Data Manager will lead and manage data management tasks for assigned studies, ensuring timely completion within budget. This includes partnering with sponsors, clinical and statistics to develop data collection specifications from all data sources.
Key Responsibilities
- Accountable for driving achievements of project milestones from study start-up through database delivery
- Provide data management input into the protocol design and guide CRF approval process
- Define and develop data management plan, data validation plan, and their annexes
- Validate the database and perform computerized checks, including SAS listings or checks
- For EDC studies, define user acceptance test plan and execute test activities in the test environment to ensure quality eCRF
- Timely response to issues identified by the eCRF Helpdesk
- Prepare CRF completion guidelines and train data-entry staff
- Perform term coding for clinical studies, raise manual queries as required, and manage query discrepancies
- Create and test import programs for electronic data received from external vendors
- Perform timely data integration of CRF and non-CRF data (data import from external sources)
- Reconcile external data (e.g., SAE, Central Labs, ECGs, etc.)
- Run and monitor study data progress reports, including query management, and take appropriate actions (e.g., escalation, re-training)
- Define and execute QC plan, lead and execute database release and database freeze activities
- Lead the DM team, coordinate other DM staff, and provide direction regarding work assignment, scheduling, and prioritizing
- Maintain continuous and appropriate communication with sponsors and share critical and general issues
- Effectively represent Data Management in internal or external meetings
About You
To be successful in this role, you should have a degree in life science, pharmaceutical, biology, or related field or at least 3 years' experience in data management. Knowledge of data management processes, Good Clinical Practice (GCP), and ICH guidelines is essential. Proficiency in MS Office Suite and one or more DM systems is required. English language proficiency is also necessary.
Benefits and Compensation
This role offers an estimated annual salary of $120,000, depending on qualifications and experience. Benefits include professional development opportunities, flexible working hours, and a collaborative work environment. We offer a comprehensive compensation package that aligns with industry standards.
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