Clinical Data Management Associate
The Clinical Data Management Associate is responsible for providing expert skills as part of the clinical data management team within the Data Management and Statistics Department to ensure that efficient and quality data management products are produced in accordance with customer requirements. The core responsibility of this role is to ensure that the clinical data review, query review and resolution is in track with the study timelines while maintaining the quality and integrity of the clinical trial data.
Responsibilities:
Manages the delivery of projects through the full data management process life cycle by fulfilling the following (including but not limited to)
- annotated CRF development.
- management of queries and warnings. processing of external data.
- reporting
- SAE reconciliation.
- update of data in the eCRF,
- coding fe.g., development and validation of codes, oversight of the coding library).
- coding review (e.g., MedDRA, CTCAE, WHO or Sponsor dependent).
- validation or participation in the UAT. development of eCRF guidelines,
- Review the SAS program outputs queries
- Provides input to the management of:
- CRF development according to Sponsor needs and protocol specifications
- Project timelines
- Quality issues
- Resource management
Performs presentations of data management activities
Manages comprehensive data management tasks pertaining to the documented project specifications Provides data management expertise and data management process improvement input to the reporting
Lead Clinical Data Manager the Principal Clinical Data Manager
Complies with the Company’s Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection
Requirements:
Up to 2 years of experience in specialized data management skills (e.g.. CRF design. SAE reconciliation, central laboratory, and/or new technologies) in a CRO, a pharmaceutical or equivalent organization
