A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Manager-Database Operations
Job Description
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. Providing Functional leadership to DB Programmer’s & Database analyst including contractors, support their onboarding, training, and mentoring.
2. Support the Function Head in hiring & talent development within the organization & performance evaluation process of junior associates as needed.
3. Provide Strategic inputs to enhance business model and meet customer requirements.
4. Subject matter expert in OC,LSH,SDTM and also carries good understanding of NCDS standards who can lead the development ,maintenance and implementation of standards. Direct vendor effort in translating data models into metadata specifications for inclusion into the MDR and authoring of SSWs.
5. Work with the Data Standards Governance Board and other global librarians and/or members of vendor metadata team to discuss technical issues with implementation of approved OC data structures for CDS use.
6. Perform impact analysis for proposed modifications to existing domains, permitted choices for discussion with Governance as necessary.
7. Direct development and testing of all new CDS Library objects needed for clinical studies (DVGs, DVG subsets, Questions, Questions Sets and Question Groups, Validation, derivations) in a provisional state.
8. Document, develop, review and maintain global library copy groups of DCMs, DCIs, Procedures, Views, maintain Form Layout Templates, Extract Macros and Key Templates DCI books for reuse of standard pages for individual trials.
9. Contribute to the review of global SOPs and business guidance/user guides directly impacting the function and providing input when applicable.
10. Ensure alignment between OC Global Library Objects and Metadata Repository.
11. Leading the LSH programming activities for all new CDS projects implemented on NCDS platform.
12. For assigned CDS clinical trials initiate data load from multiple source systems (OC/RDC, WDCS, Watson LIMS etc) into the data warehouse and communicate with all affected parties, Quality Manager, Data Manager, Database Programmer, CRO/CPO personnel and other Third Party vendors as needed.
13. For studies in scope monitor data extraction, data loading and processing during study conduct, i.e. review job logs, address error / failure notifications, blinding process of Third Party data, eLoader Process; monitor staging, pre-conformance, conformance and post-conformance of all data. For database lock of studies in scope, un-blind and lock staging and conforming work areas
14. Review Data Transfer Specifications (DTS), grant access to vendor/CRO for loading data into WDCS and external data loading thorugh eLoader
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Candidate Profile
University or college degree in life science, pharmacy, nursing statistics, biostatistics or equivalent relevant degree Fluent English (oral and written).
1. Advanced knowledge/understanding and experience of applications like Oracle Clinical and standard reporting systems like CDISC/SDTM and introductory level SAS skills.
2. Ideally 6 or more years’ experience in drug development, with at least 3 years in Data Management activities.
3. Experience in managing outsourced studies or working for a CRO.
4. Thorough understanding of physiology, drug development process, clinical trial methodology, GCP, medical terminology, and coding.
5. Project team leadership experience; 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 Information:
Job ID: 139922BR
Experience: Min. 6 Year
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Development & Medical
Location: Hyderabad
End Date: 30th April, 2014
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