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 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 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.
Novartis is an EEO/AA employer M/F/D/V. This position will be filled at a level commensurate with experience.
Bach. degree is necessary (pref. life sciences, nursing, etc). Masters degree a plus Fluent English (oral and written) 1. Five or more years experience in drug development from a pharmaceutical, biotech, or CRO firm, 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.