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Senior Clinical Data Manager


Source:
TIMESJOBS.COM
Location:
Secunderabad, Telangana
Date:
13-11-2016
Job Code:
58271880
Categories:
  • Biotechnology & Science
Applying for this job will take you to an external site
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Job Details

1.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.
Degree: M.Pharm. (Pharmacy) | M.Sc. (Science) | MD/ MS (Medicine)

Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science) | MBBS

Experience: 6-11

Requirements

Clinical Research | Data Management/ Statistics | Documentation/ Medical Writing | Quality Assurance/ Control
Applying for this job will take you to an external site

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