Clinical Data Specialist Information

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Novartis Healthcare Pvt Ltd

Novartis (NYSE: NVS) is a world leader in the research and development of products to protect and improve health and well-being. The company has core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health. Headquartered in Basel, Switzerland, Novartis employs nearly 115 000 people in over 140 countries worldwide to help save lives and improve the quality of life. The Group is present in India through Novartis India Limited, listed on the Mumbai Stoc... Read More

Address	Sandoz House Shivsagar Estate Dr Annie Besant Road Worli, Mumbai India
Website	www.novartis.in/
Holding	No Holding Details

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Clinical Data Specialist

Provide timely and professional ongoing management of clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s) with respect to cost, quality and timelines. 1.Provide professional DM input on Clinical Trial Team(s) 2.Input to and review of clinical trial database design including User Acceptance Testing (UAT). 3.Provide input for the Validation and Analysis Plan (VAP) meeting for the clinical trial, which includes taking an active part in the meeting, providing input in writing the study specific validation checks and necessary reports to ensure high quality and consistent data. 4.Identify errors and inconsistencies; resolve them or initiate their resolution either via the field monitor or directly with the investigational site, to ensure high quality and timely database locks. 5.Review and contribute to preparation of protocols, specifically related to the data management section, visit schema and study design with supervision. 6.Prepare Case Report Forms (CRFs) and CRF completion Guidelines (CCGs), electronic or paper. 7.Support and assist data management staff for allocated trials. 8.Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock. 9.Perform training on data management software and practices or trial specific topics as required. 10.May participate in preparation of training materials for data management activities and processes. Desired Profile University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant de-gree. Fluent English (oral and written). 1.Minimum of 2 years experience in drug develop-ment and at least 1 year experience in Data Man-agement 2.University Science Degree in life sciences, phar-macy, nursing or equivalent relevant experience. 3.Excellent written and oral English skills 4.Understanding of clinical trial methodology, GCP and medical terminology 5.Good computer skills 6.Good organizational and project management skills. 7.Good communication and interpersonal skills 8.Basic presentation and problem solving skills 9.Ability to work well in a team with or without su-pervision Experience 1 - 3 Years Industry Type Pharma / Biotech / Clinical Research Role Chemical Research Associate/Scientist