Job Description and Requirements: Oracle Clinical Data Manager
Position reports to Manager, Data Management. Responsible for managing data management activities, interfacing with Clinical Operations on behalf of the Data Management Department to ensure that standards are communicated properly, that timelines are met according to objectives and goals and that data reporting needs are scheduled and addressed and that the quality of data management deliverables are monitored.
Duties Include: Review CRF design; Create CRF Completion Guidelines/Mock CRF’s and coordinate their review and approval; Review and approve Data Management Plan components, i.e., study summary/data flow diagrams, timelines, critical variables list, etc.; Review Data Validation Specifications and coordinate input for Biometrics/Data Management Departments to ensure that Statistical Analysis Plan (SAP) requirements will be met; Specify data review tools to be included in the data validation process to ensure that safety and SAP requirements are met; Represent department on clinical trial team, project management and status reporting; Handle AE/SAE reconciliation;Monitor external batch data loading and any CRF to electronic data;Inventory reconciliation; Ensure that timelines for data deliverables are met by requesting/reviewing metric reports, keeping internal clinical teams informed regarding project status and issues as they arise;Contribute actively to the review of working practices and the development of SOP’s.
Candidate may be required to represent Client at Investigator Meetings and internal clinical meetings which requires travel up to approximately 10%. Candidat may also carry out mentoring responsibilities with Clinical Data Coordinators.
Bachelor’s Degree in Life Sciences, Pharmacy or Nursing with 6 or more years of experience in drug development and the discipline of data management or an equivalent combination of training and experience.
Four years of experience in Oracle Clinical data management system and familiarity with SAS required.
Job Description and Requirements: Oracle Clinical Data Manager
Position reports to Manager, Data Management. Responsible for managing data management activities, interfacing with Clinical Operations on behalf of the Data Management Department to ensure that standards are communicated properly, that timelines are met according to objectives and goals and that data reporting needs are scheduled and addressed and that the quality of data management deliverables are monitored.
Duties Include: Review CRF design; Create CRF Completion Guidelines/Mock CRF’s and coordinate their review and approval; Review and approve Data Management Plan components, i.e., study summary/data flow diagrams, timelines, critical variables list, etc.; Review Data Validation Specifications and coordinate input for Biometrics/Data Management Departments to ensure that Statistical Analysis Plan (SAP) requirements will be met; Specify data review tools to be included in the data validation process to ensure that safety and SAP requirements are met; Represent department on clinical trial team, project management and status reporting; Handle AE/SAE reconciliation;Monitor external batch data loading and any CRF to electronic data;Inventory reconciliation; Ensure that timelines for data deliverables are met by requesting/reviewing metric reports, keeping internal clinical teams informed regarding project status and issues as they arise;Contribute actively to the review of working practices and the development of SOP’s.
Candidate may be required to represent Client at Investigator Meetings and internal clinical meetings which requires travel up to approximately 10%. Candidat may also carry out mentoring responsibilities with Clinical Data Coordinators.
Bachelor’s Degree in Life Sciences, Pharmacy or Nursing with 6 or more years of experience in drug development and the discipline of data management or an equivalent combination of training and experience.
Four years of experience in Oracle Clinical data management system and familiarity with SAS required.