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Lead Analyst-Database Operations

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

Ensure quality and timely delivery of clinical databases for multiple CPO local studies and projects outsourced to CROs and establish appropriate application of data standards, direct and monitor CRO progress and perform quality assurance review of key clinical database development deliverables.1.Basic knowledge in OC,LSH, SDTM and also carries good understanding of data standards who can lead/assist the development ,maintenance and implementation of standards. 2.Work with the Governance/approval Board and other DB operations associates and/or members of vendor metadata team to discuss technical issues with implementation of approved OC data structures for CTS use. 3.Ensure alignment between OC Global Library Objects and Metadata Repository. 4.Understanding and Leading the Life Science Data Hub (LSH) programming activities for all new CTS projects implemented on Novartis Clinical Data Standards platform. 5.For studies in scope initiate data extraction, pre-conformance, conformance and post-conformance of clinical data into NCDS standards based on study conformance plan and ensure data refresh as per the schedule 6.For studies in scope monitor data loading and processing during study conduct, i.e. review job logs, address error / failure notifications, blinding process of Third Party data, Compliance with relevant Global and CPO code-of-conducts and various regulatory requirements.Timely and high quality completion of outsourced database development deliverables according to study objectives and applicable Novartis standards including standards development, CRF Design, database specifications, interim data cuts, and final database lock. No database unlocks due to avoidable database issues.Minimum requirementsUniversity or college degree in life science, B.Pharma,Statistics, Biostatistics or equivalent relevant degree. Fluent English (oral and written). 1.Basic knowledge/understanding and experience of applications like Oracle Clinical and standard reporting systems like CDISC/SDTM. 2.Ideally 4 or more years experience in drug development, with at least 2 years in Data Management activities. 3.Experience in managing outsourced studies or working for a CRO is desirable. 4.Thorough understanding of physiology, drug development process, clinical trial methodology, GCP, medical terminology, and coding. 5.Good organizational and project management skills. 6.Good technical and problem solving skills. 7.Ability to work independently, under pressure, demonstrating initiative and flexibility. 8.Attention to detail and quality focused. 9.Good interpersonal and communication skills and ability to operate effectively in an international environment. 10. Good negotiation skills. 11. Ability to mentor, coach within Data Management and cross functionally, and train internal and external partners.
Additional Degree: B.Pharm. (Pharmacy)

Experience: 4-9


Admin Services/Medical Facilities | Clinical Research | Documentation/Medical Writing
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