A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Clinical Data Manager / Senior Clinical Data Manager
Provide timely and professional ongoing management of project & clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard databse(s) with respect to cost, quality and timelines.
1. Serve as Project Data Manager for large projects or multiple smaller projects providing professional Data Management input on ICT(s).
2. Responsible for ensuring consistency of protocols, Validation and Analysis Plans (VAPs) & Project eCRFs for all trials within assigned projects.
3. Business understanding of the compound profile (CDP/TPP) to identify and assist in successful application of data management processes.
4. Respond to Health Authority requests for data management issues.
5. Support and assist Assistant Data Managers and other Data Managers for allocated trials within assigned project(s).
6. Provide input, review, and maintenance of global working practices and standards.
7. Contribute to the development of the Data Management organization through his/her leadership role within the DM Group.
8. Track and report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases. Ensure appropriate Novartis tracking systems are up to date and accurate.
9. Lead and support clinical & non-clinical special projects.
10. May deputize for Data Management Group Head and assist in coaching, training and mentoring of Data Management staff.
- University or college degree in life sciences, computer science, pharmacy, nursing or equivalent relevant degree.
1. Ideally 5 or more years experience in drug development, with at least 4 years in Data Management activities.
2. Project team leadership 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 organizational, planning and project management skills.
8. Good interpersonal and communication skills and ability to operate effectively in an international environment.
9. Good negotiation skills.
10. Thorough understanding of physiology, pharmacology, clinical study objectives and the drug development process.
11. Ability to mentor, coach within Data Management and cross functionally, and train internal and external partners.
Experience: Min. 5 Years
Education: M.Pharm, M.Sc - Life Sciences
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Job Type: Full Time
Employment Type: Permanent
Job ID: 77586BR
End Date: 8th Nov., 2011
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