Vacancy in Panacea Biotec for the post of Sr. Executive (Clinical Data Management) B3

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: 19^th July, 2014

Apply/Forward your Resume, corporate@panaceabiotec.com