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Vacancy in Panacea Biotec for the post of Sr. Executive (Clinical Data Management)


Clinical courses


Clinical research courses

Panacea Biotec is a leading research based Health Management Company, with an annual turnover of approx. Rs. 830 Crores. We are engaged in research, development, manufacture & marketing of Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of international quality and Health Services. All Panacea Biotec plants are accredited by international agencies and they follow current Good Manufacturing Practices, as per WHO guidelines.
We offer stimulating work environment & a career that spells growth. In tune with our plans, we require young, aggressive, dynamic, high performing and result oriented professional.

Post: Sr. Executive (Clinical Data Management)


Job Description

  • Responsible for programming of edit checks based on the approved edit specifications document.
  • Create, implement and execute validation procedures to build and maintain discrepancy database set-up for paper based and/or web based (RDC) clinical data management systems (CDMS) in standard format.
  • Create and review (electronic) Case Report Forms per Protocol and Annotated Case Report Forms
  • Write, review and maintain eCRF completion guidelines, data management plan(DMP), Data Validation Plan (DVP, e.g.
  • Perform or assist in  all aspects of DM process as related to processing QC /review/ UAT and subsequent updation of the findings of the data.
  • Write and review DM SOPs in accordance with GCO and ICH guidelines, develop associated training and competency testing
  • Clean data for study close out and perform all database lock procedures
  • Work in conjuction with Clinical Operations, Clinical Research, and other operations to ensure, accurate, efficient and complete data collection
  • Contact Metalink and/or Oracle Clinical User Group for validation related issues. As required, based on the response shall suggest IT team about bug fixation / patch updation.
  • Solve operational problems related with database (front end) and CDM processes.
  • To perform all related activities of data management like data entry, data coding, data reconciliation and SAE.
  • To assist manager in holding QA audits and  providing Corrective and Preventive action plan.
  • Must have experience in CDM with more than 3 years
  • Well versed with Oracle Clinical/ Remote Data Capture (OC/RDC) specially programming, SQL, PL SQL.


Additional Information:
Experience: 3-4  Years
Age: 22-40 years
Location: Delhi
Education: B.Com/B.Sc/B.Pharma etc & Diploma/degrees in Information Technology(IT)/Profesional qualification etc

Industry Type: Pharma/Biotech/Vaccines
Functional Area: CR
Last Date: 19th July, 2014

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