Job Title
Clinical Data Manager/Clinical Database Analyst
Job Duties
Clinical Data Management in therapeutic areas of Oncology, Neuroscience, Vaccines, Dermatology, Cardiovascular, CNS and Diabetes. Data Management in different phases (Phase I, II, III and IV) of Clinical Trials.
Using Oracle Clinical, OC-TMS, OC-RDC, OC Reporting Tools, Oracle Discoverer, Integrated Review, InForm and Medidata Rave. Follow industry standards including 21 CFR Part 11, ICH GCP, CDISC, Good Pharmacovigilance Practice standards, clinical safety regulations and guidelines. Coding of MH, AE, SAE, investigations, surgical procedures and Drug terms to MedDRA and WHODrug Dictionaries.
Coding terms using BNF, COSTART, ICD and WHOART dictionaries.
Handle multiple projects and study activities starting from Review of protocol and supervision of all DM activities from Study Start up to Database Lock. Full data management lifecycle activities. Creating and Maintaining Data Management Plan. Review of Study Metadata, Edit Check specifications and User Acceptance Testing. Operational EDC management. Discrepancy Management. Safety Data Review and SAE Reconciliation.
Lab data Review. Review and Reconciliation of third party data: ECG, IVRS, PK, PD, Biomarkers, MRI. Provide inputs for the DM components in the Protocol.
Special Requirements
Windows, Oracle Clinical, Medidata Rave, OC-RDC, Oracle, Oracle Discoverer, IReview, InForm EDC, MS Office, Visio, MS Project, MeDRA Dictionary, WHO Drug Dictionary, Good Clinical Practices (GCP), Lean Six Sigma and Six Sigma
Travel Requirement
Number of Positions
Education Requirements
Compensation
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Job Open
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