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Senior Clinical Data Manager

Mumbai, MH
Job Code:
  • Biotechnology & Science
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Job Details

Provide Functional/ technical Data Management leadership for multiple trials/CSU or mega trials; Provide input on CTT(s)/GCT (s) in addition to own study assignments.2.Provide inputs ensure consistency of Protocols, Validation and Analysis Plans (VAPs)/Data Handling Plans (DHP) & eCRFs for all trials within assigned projects. 3.Responsible for contributing to protocols and preparing the eCRF, VAP/DHP, database design testing (UAT), identifying errors and inconsistencies, freezing and locking database as appropriate).4.To coordinate DM input and compile decisions taken to build project standards and starting knowledge sharing on those with CSU DS 5.Ensure work carried out under the DM Alliance is in accordance with SOPs and Working practices and agrees deviations to the DM Alliance service level agreements for the Franchise CSU/Disease Area 6.May respond to Health Authority requests for data management issues.7.Support Expert Data Manager and other Data Managers in the team for allocated trials within assigned project(s). 8.Provide input, review, and maintenance of global working practices and standards.9.Ensure smooth and successful implementation of iDMA model, driving change and implementing new process and training 10.Coordinate with the Data Management Team Lead to track and report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases.11.Coordinate with Team Manager within iDMA to ensure that trial is managed efficiently with high quality. 12.Ensure appropriate Novartis tracking systems are up to date and accurate.13.Participate in clinical & non-clinical special projects. 14.Assist in coaching, training and mentoring of Data Management staff.15.Efficient collaboration with the team from Shared Services within iDMA to ensure timely deliverables with high quality. Novartis is an Equal Opportunity Employer.Minimum requirements1.Broad experience (approx. 6+ years) in clinical development, specifically in Data Management2.Strong Trial Management experience required. 3.Good technical and problem solving skills.4.Thorough understanding of clinical trial methodology, GCP and medical terminology. 5.Ability to work independently, under pressure, demonstrating initiative and flexibility.6.Attention to detail and quality focused. 7.Good organization and planning skills.8.Basic project management skills. 9.Through understanding of physiology, pharmacology, clinical study objectives and the drug development process.10.Ability to mentor and coach within Data Management
Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 6-10


Data Management/ Statistics | Documentation/ Medical Writing | Drug Regulation
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