Require Assistant Data Manager at CDSA | Salary Rs. 40,000/- pm
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.
Post : Assistant Data Manager, CDM (District Hospital Study funded by BMGF)
Emoluments/ Duration : (Rs. 40,000/- per month consolidated) for 24 Months.
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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