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Clinical Data Manager – Novartis

The Novartis is looking for an interested candidate for the position of Clinical Data Manager to provide timely and professional ongoing management of clinical trial data.

Position Requirements:

  • University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant de-gree. Fluent English (oral and written).
  • Two or more years experience in drug development with at least 2 years experience in Data Management.
  • University Science Degree in life sciences, pharmacy, nursing or equivalent relevant experience.
  • Excellent written and oral English skills
  • Understanding of clinical trial methodology, GCP and medical terminology. Good computer skills. Good organizational and project management skills.
  • Good communication and interpersonal skills. Intermediate presentation and problem solving skills
  • Ability to work well in a team. May coordinate and provide direction on task to other data management team members.
Employer Novartis
Posted 06-062016
Location Hyderabad, India
Discipline NA
Salary NA
Official Notice

Responsibilities:

  • Provide professional DM input on Clinical Trial Team(s). Input to and review of clinical trial database design including User Acceptance Testing (UAT). Responsible for the Validation and Analysis Plan (VAP) meeting for the clinical trial, which includes chairing the meeting, writing the study specific validation checks and necessary reports to ensure high quality and consistent data.
  • 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. Review and contribute to preparation of protocols, specifically related to the data management section, visit schema and study design.
  • Prepare Case Report Forms (CRFs) and CRF completion Guidelines (CCGs), electronic or paper. Support and provide leadership for data management staff for allocated trials. Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock.
  • Perform training on data management software and practices or trial specific topics as required. Prepare training materials for data management activities and processes as required.
  • Travel is required as needed.Meet established KPIs. Timely and high quality completion of Data Management deliverables according to established objectives, including: CRF Design, UAT of eCRF, Fast and high quality Database Lock, EDC User Training.Meet established KPIs. Timely and high quality completion of Data Management deliverables according to established objectives, including: CRF Design, UAT of eCRF, Fast and high quality Database Lock, EDC User Training.

Novartis was created in 1996 through the merger of Ciba-Geigy and Sandoz and has a rich history spanning over 200 years. It was ranking number one in sales (57.9 billion US$) among the world-wide industry in 2013. In July 2015, Novartis had a market-cap of around $280 billion[3] making it the largest healthcare company by this metric. They have a talented and diverse workforce of more than 119 000 people of 150 nationalities.

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