Job for Quality Analyst at Clinical Development Services Agency | Emoluments Up to Rs. 60,000 pm

Clinical Development Services Agency (CDSA) mission is to create, develop, nurture world class clinical product development capacity in India.
CDSA invites applications from high performing professionals with a desire to serve public health needs of the country for the below mentioned administrative position

Post : Quality Analyst (bOPV Study)

Emoluments & Duration : Up to Rs. 60,000 per month, consolidated for 15 Months

Location : CDSA (THSTI), NCR BioScience cluster, Faridabad

Job profile Activities

  • Manage all stages of data management quality management activities from study startup to database close
  • Development of database build specificationsProgram 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
  • 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
  • Ensure data processing activities are performed according to protocol, GCP and SOPs
  • Generate ad-hoc reports as needed
  • Coordinate the archiving of study databases and related documents

 

Work relations (context – main interfaces functional report)
Interfaces with Director (Clinical Data Management), Data Manager, Project Manager, Database Administrator, Database Designer, SAS Programmer, Clinical Data Coordinator, Data Entry Operator, Medical Coder, Medical Affairs & Medical Writing, Biostatistics, Central Laboratory, other Heads of Departments and Administration team

Critical Deliverables
1. Performing day-to-day clinical data quality control and data processing according to the principles of Good Clinical Practice
2. Resolving DCFs related to safety and efficacy panels enable data cleaning leading to qualitative database
3. Effective generation, resolution and updation of DCFs
4. Quality Check of Database Design, Validation Program, Annotated CRF, Data Extract Views, Laboratory Details, Site and Investigators and Final Data Listings

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