Career opportunity for the post of Lead Data Manager in Novartis

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: Lead Data Manager

Job Description
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 database(s) with respect to cost, quality and timelines.
1. Serve as Trial Data Manager for multiple trials and may act as a PDM for small study programs; Provide input on CTT(s)/GCT (s).
2. Assist Project Data Manager to ensure consistency of Protocols, Validation and Analysis Plans (VAPs) & eCRFs for all trials within assigned projects.
3. Responsible for contributing to protocols and preparing the eCRF ,CCG, VAP, da-tabase design testing (UAT), identifying errors and inconsistencies, freezing and locking database as appropriate).
4. May 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 local Data Management group through his/her leadership role within the 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.
9. Ensure appropriate Novartis tracking systems are up to date and accurate.
10. Participate in clinical & non-clinical special projects.
11. Assist in coaching, training and mentoring of Data Management staff.

Candidate Profile
University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree. Fluent English (oral and written).
1. Ideally 4 or more years experience in drug devel-opment, with at least 3 years in Data Management activities.
2.Trial Management experience required.
3. Good technical and problem solving skills.
4. Thorough understanding of clinical trial method-ology, 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, pharmacol-ogy, clinical study objectives and the drug devel-opment process.
10. Ability to mentor and coach within Data Manage-ment.

Additional Information:
Experience: 3-4 Years
Location: Hyderabad
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Division: Pharma
Job Type: Full Time
Employment Type: Regular
Job ID: 135492BR
End Date: 21^th Feb, 2014