Applications are invited for post of Consultant at under Division of ECD at ICMR | Salary Rs 1 Lakh per month
The lndian Council of Medical Research (ICMR), New Delhi, the apex body in lndia for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world.
Following posts is to be filled purely on contractual basis for working under the programme entitled 'lndia TB Research Consortium' (ITRC) under Division of Epidemiology and Communicable Diseases (ECD), ICMR Hqrs Office, New Delhi.
Post : Consultant (Data management)
Essential Qualification Minimum Experience required :
Professional with M.Sc (Bioinformatics)/ B.tech(Bioinformatics)/M.Tech (Bioinformatics) with strong Data Science background and 5-7 years of experience in data management in research/Bioinformatics. Working knowledge of Clinical Database Development tools will be preferred or Ph.D (Bio-Statistics) with 4-6 years of experience in data management in Clinical Research/clinical Trials with strong Data Science background/Bioinformatics. Working knowledge of Clinical Database Development tools will be preferred Or Retired government employee with above mentioned educational qualifications and experience and drawing pay in pay band of Rs.15,600-39100+grade pay of Rs.6600/-at the time of retirement.
Age Limited as on date: up to 70 years
• Doctorate in Bioinformatics or relevant subject from a recognized University.
• Additional Post-Doctoral research/2YRS teaching experience in Bioinformatics in recognizedinstitute(s) after obtaining essential qualification.
• Strong Knowledge of use of Bioinformatics tools.
• Ability to work on a number of projects in parallel
• Ability to work independently and as a part of a team
• Close attention to detail, timelines and quality and Good planning and organization
• Thorough knowledge of ICH, GCP and regulatory requirements Or Well-versed in regulatory requirements for validation of data management systems, GxP, Good Clinical Data Management Practices (GCDMP)
• Excellent command of English, Good PC user knowledge, Proficient in Microsoft Office applications, internet, Email
• Sound understanding of the global drug development process
• Ability to develop/advise on training programs
• Familiarity with SAS programming
• Additional Experience preferred in various phases of clinical trials with full project life cycle experience (CRF design to database lock and reporting); use of commercial and/ or proprietary clinical data management systems, coding dictionaries/ encoding systems (e.g. MedDRA, WHODRL), other software in support of data management activities (e.g SAS, Access, SQL, Oracle), programming skills and experience with electronic data capture a definite plus
• Knowledge of validating the system
Nature of Duties
1. Work on research projects available with the centre.
2. Providing data management and analysis services requested by the users of the Centre
3. Work on collaborative research projects initiated by the Exploratory Team
4. Providing technical support to the Exploratory Team (if required)
5. Providing assistance to medical research groups on using different tools and techniques for their research.
6. Data Validation and ongoing Quality Control
7. Query Management: generate and reconcile queries
8. Maintain study data and data management documents
9. Training of data entry staff
10. Participate in CRF development, CRF annotation, database design and screen design and Database testing
11. Coding of medication, therapies and adverse events
12. Workflow development
13. Continual liaison with internal and external users
14. Take responsibility for managing Clinical Data Management.
15. Provide technical leadership, resource management and project management for the required technical aspects supporting CDM activities.
16. Ensure quality, timeline and productivity requirements are met or exceeded. Included in this are project planning and implementation, milestone tracking, organization and participation in team meetings, monitoring progress and providing updates as required
17. Create, direct and maintain strategies in line with the Clinical Operations and/or Bioinformatic organization to help facilitate efficiencies within the department.
18. Manage a team local to a site to provide work direction task prioritization, supervision, assistance and career development to assigned tasks.
19. Manage all phases of data management activities from study start up to database close and not limited to database set-up, CRF design, data entry, validation/ edit checks, data transfer, and any ad-hoc programming required to support a clinical trial process
20. Lead cross-functional meetings and drive initiatives to ensure the delivery of milestones and timelines for clinical studies.
21. Identify and adequately resolve operational and technical problems. Manage process improvements.
22. Communicate with the other operational groups regarding workflow, process, timelines, and resource planning to ensure transparency between the all functions as well as any external support groups.
23. Define, develop and deploy appropriate operating procedures.
24. Work closely with the Quality Management Groups (QMG) to ensure compliance with SOPs/ Guidelines, GCP and any other applicable local regulations.
25. Provide relevant training/mentoring for staff to assist them in resolution of problems encountered in the conduct of their daily work or on application of Clinical Systems.
26. Co-ordinate the improvement and implementation of tools, including, but not limited to standard project directories and subdirectories, document file names and status reports that result in improved efficiencies and quality.
27. Attend (as appropriate) client facing meetings to represent the CDM group on activities including, but not limited to, progress reviews, technical updates on key milestones, bid defences, technical requirements collection.
28. Represent the CDM group at internal and external audits and regulatory inspections, as required.
29. Create and review case report forms as per protocol.
30. Creation of annotated CRFs
31. Development of data entry filling guidelines, data management plan, data validation plan/ edit checks documents and other DM related documentation
32. Database validation – Ensures 100 % execution of Quality Control (QC) testing and User Acceptance Testing (UAT)
33. Develop, review and maintain clinical databases
34. Data quality check, Query management and data merging and Ensures 100% clean data for safety and efficacy for the study.
35. Data Cleaning for study close out and perform all database lock procedures
36. Report generation as and when required
37. Provide DM activities status to the team on daily basis
38. Overall responsible for all the activities of assigned project. Change Requests and takes approval from sponsor
39. Write and review DM SOPs in accordance with GCP and ICH guidelines and develop associated training and competency testing
40. Maintain CRF’s and database standards work in conjunction with clinical operations, clinical research and other operations to ensure accurate, efficient and complete data collection
41. Responsible for performing all aspects of DM process as related to processing and Quality Check of the data.
42. Ensures all DM procedures executed with a high attention to detail, accuracy and timelines
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