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Clinical Data Management

India has grown into a super power for IT skills and has become a major hub for pharmaceutical and biotech manufacturing and contract research, though outsourcing in various other segments is also promising.

Clinical trial data management and statistical analysis is one of those fields which is growing rapidly, followed by a variety of players joining different business models. The author explores the data management market in India and discusses new outsourcing models in this growing industry.

He also sought to establish a break-even analysis taking into account the expected investment in high quality and expensive facilities, such as hardware, software and human resources, in order to increase the market and regulatory requirements of the sector.

Work Profile

Clinical Data Analyst/ Manager

Job Description

The primary responsibility is to ensure the quality and format of clinical trial data for statistical purposes. It also develops analysis tools, sets up databases and records, and controls the flow of data to and from investigation sites. With supervision, develop protocol-specific data analysis and entry guidelines for recording data validation and formatting procedures and identify batch-extinguishing programs. Timely data entry controls.

Reviews the gaps in the resolution of the investigation sites and enters the corrections in the network, as needed. Assist in the analysis of interim / final data listings prior to dissemination to other groups or inclusion in interim / final studies. Knows the database management frameworks and the concepts, structure and material of the Standard Case Report Form (CRF) libraries. Ensure that the incoming CRFs are monitored in a timely manner prior to the safety review and the manual review.

It is familiar with the coding of standard operating practices (SOP) data and the coding of dictionaries. Conducts database audits on the basis of SOPs and is familiar with the application of GCPs.

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