Junior Data Manager
6 months ago
Manage assigned data management project and provide leadership to the data management teams.
- Provide staff training for all projects to which assigned.
- Reviewing data for completeness and consistency
- Ensure adequate QC checks and Database Quality Assessments on the clinical databases
- Ensure timely database locks for all assigned projects.
- Designing CRF as per the sponsor protocol
- Developing Data Validation Plan
- Validation/Discrepancy Management
- CRF annotation
- Coordination of data management and biostatistics activities within a project
- Mentoring and training less experience/Data Administrators
- specific coding tools - MedDRA, WHO drug dictionary and other recognized pharmacopoeia to ensure correctness of coding
- Write clear and concise queries for coding clarification
- Identify the need of study specific coding conventions
- Create and maintain study specific coding conventions when required
- Assist and support clinical data managers in order to identify the specific coded panels and dictionaries / versions to be used
- Coordinate with clinical data managers regarding timing of import / exports of data to the client
- Review coding listings to ensure accuracy and consistency of coded data
- Participate in internal project team meetings and facilitate efficient project communication
- Participate in database lock process and snapshots and ensures that all coding steps prior to locking the database are complete
- Prepare Data Cleaning Specification. Review the Data Validation Specification
- Develop or provide input to project specific guidelines, e.g. SAE handling
- Initiate the running of study specific programs
- Identify and report protocol violations
- Lock site(s) within EDC system - remove user's data modification privileges. Interact with site (via mail) as required
- Perform early and final database QC activities
- Update all relevant tracking system on an ongoing basis
- Keep Manager informed about work progress and any issues to avoid surprises. Requires some interaction / supervision by Manager or assigned mentor.
- Provide consultation, facilitate metrics collection and develop action plans in conjunction with Management to keep project on time and within budget.
- Resolve escalated quality issues.
- Represent Operations Quality Management in audits and inspections as required.
- Perform other duties as assigned.
**Qualifications**:
- Education: Pharmacist / Medicine / Dentist.
- Experience: at least 2 years in Data manager
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