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Clinical Data Associate Senior
Rare Disease Registries
The Clinical Data Associate Senior position will provide leadership and comprehensive data management expertise in in all aspects of data management.
Proven ability to collaborate with project teams and peers, coordinate consultants, manage vendors, and to bring large-scale projects to successful completion.
Responsible for the development and maintenance of data collection tools and processing of clinical data for longitudinal observational rare disease registries in support of scientific, clinical, regulatory and commercial goals.
Participate and take leadership role for data management in project team meetings to discuss evolution and issues for ongoing registry program.
Foresee data management project issues needing to be brought to the attention of management, or other functional departments.
Oversee the Functional Service Provider (FSP) in data validation engagement to ensure clinical data are processed according to the Data Review Guidelines (DRGs) and Standard Operating Procedures (SOPs).
Lead the project team in the development, review and approval of Case Report Forms (CRFs).
Collaborate with programming team to define requirements for data listings to utilize in manual data review.
Coordinate with highly motivated and experienced Data Management and Site Operations team to identify potential problems with data collection and data quality and suggest methods for improving processes and workflows to ensure good quality data.
Collaborate with data management team in the development of global, inter-departmental harmonized SOPs, and registry specific guidelines for patient workflow (enrollment, transfer) and processing clinical data.
Collaborate with data management team and other functional departments to define and develop operational type reports to assist with data exploration and metrics.
Review data listings to resolve data trends.
Create, implement and maintain data management procedures and workflow documentation, to include, but not limited to: Data Review Guidelines, eCRF Completion Instructions, Data Validation Plan and Data Management Plan.
Perform data management tasks according to GCP, approved SOPs and protocol.
Maintain the following documents for the clinical database in Electronic Data Capture (EDC); database specifications, data validation (edit checks) specifications, report specifications and other functional specifications.
Track and maintain project level documents in designated electronic storage space for compliance reviews.
Develop data management QC plans and quality control checks for the processing of clinical data.
Perform periodic QC of all reviewed and queried data.
Oversee query management, manual review, and all daily data management activities for assigned projects.
Responsible for ensuring clinical data are well-validated and ready for statistical analyses.
2-4 years of experience in developing database and validation specifications
2-4 years of experience with Electronic Data Capture (EDC)
1-2 years of experience with Reporting Tools (e.g., BOXI, SAS, Business Objects)
1-2 years of experience in writing SOPs, Work Instructions, Data Management Plans and Guidelines
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