Last Date: 5th March, 2019
Clinical Development Services Agency
NCR Biotech Science Cluster, 3rd Milestone
THSTI Building, Faridabad-Gurgaon Expressway
Faridabad, Haryana 121001
Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India launched CDSA on 28 September 2009 as an autonomous organisation and extramural unit of Translational Health Science & Technology Institute (THSTI). It was created to facilitate development of affordable healthcare products for public health diseases. Registered as a not-for profit research organization, it aims to develop an eco-system for training and learning and work with public sector institutions, and small and medium enterprises (SME) to translate innovative technologies into medical products for public good.
1.Name of the post- Assistant Data Manager
Pay Scale- Rs.40,000/- per month
External Relationships: Clients and Vendors
• Manage all stages of data quality management activities from study startup to database close.
• Development of database build specifications and Data management plan
• Program procedures to validate the data in the database and perform testing of the same with test patient data (UAT)
• Develop edit check and data derivation procedures to support implementation of new clinical trials.
• Test and execute validation procedures.
• Perform the database testing and database audit as part of Quality Control
• To complete database close / lock / freeze checklists.
• To perform reconciliation of the clinical database against safety data, laboratory data and other third party data as appropriate.
• Review CRF / eCRF data entry conventions
• Performing day-to-day clinical data quality control and data processing according to the principles of Good Clinical Practice
• Interact with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project
• Preparing interim reports for clinical trial status and participating in data extraction in collaboration with the statistician
• Review interim listings for of data as needed.
• Maintaining clinical study documents
• Testing new processes and systems for the management of clinical trials
• Participates in cross functional team meetings & external client meetings as DM representative
• Quality Check of Database Design, Validation Program, Annotated CRF, Data Extract Views, Laboratory Details, Site and Investigators and Final Data Listings
• Ensure data processing activities are performed according to protocol, GCP and SOPs
• Coordinate the archiving of study databases and related documents Generate ad-hoc reports as needed.
• Familiarity with GCP, US-FDA 21 CFR 11, regulatory requirements and data standardization guidelines.
• IT literate (experience with Microsoft based applications and other CDMS applications)
• Must have experience in handling EDC tools
• Validation programming
• Must have understanding of clinical trials and familiarity with clinical data management functions.
• Good interpersonal, verbal and written communication skills.
• Client focused approach to work.
• A flexible attitude with respect to work assignments and new learning.
• Meticulous attention to detail.
• Effective time management in order to meet metrics or team objectives.
• Commitment to project and team goals.
• Must be able to work independently but seek guidance when necessary.
• Team player with outstanding inter-personal, negotiation skills and organizational skills.
• Sense of urgency in completing assigned tasks
• Exhibits a sense of urgency about solving problems and completing work.
• Shows commitment to and performs consistently high quality work.
• Ability to model behaviours and ethics in line with CDSA Mission and Vision.
Qualifications and Experience
• Educated to Master’s degree level in healthcare field, IT, Computer Applications or equivalent experience. Minimum Work Experience 4-5 years in clinical data management (Clinical Data Manager/ Data Validation Associate/ Data Quality Manager) . Advantageous Experience: Familiarity with industry standard CDMS and SAS programming.
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