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

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)

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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.

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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