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 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 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, database 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.
Excellent written and oral English skills
Trial Management experience required.
Good technical and problem solving skills.
Thorough understanding of clinical trial methodology, GCP and medical terminology.
Ability to work independently, under pressure, demonstrating initiative and flexibility.
Attention to detail and quality focused.
Good organization, planning and project management skills.
Through understanding of physiology, pharmacology, clinical study objectives and the drug development process.
Ability to mentor and coach within Data Management.
University Science Degree in life sciences, pharmacy or nursing with 4 or more years experience in drug development with at least 3-5 years experience in Data Management.OC-RDC experience preferred.
Experience: 4-5 years
Education: B.Pharm, B.Sc
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Development & Medical
Job ID: 65028BR
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