Job Description :
The digital revolution is dynamically changing the roles and the responsibilities of a Clinical Data Manager (CDM) in the pharmaceutical industry due to the diversity of data now being collected and used in clinical trials and determine which patients are most likely to have the most benefit from these innovative therapies. At Novartis, we have more than 20 years of data and its volume is growing continuously from a diverse portfolio of diseases that are being explored to deliver the best innovative medicines to patients.
Come to an industry leader where you will contribute to protocol development, take responsibility and lead all aspects of data management work for assigned studies/projects from multiple therapeutic areas done in-house or outsourced to Contract Research Organizations (CROs). Ensure quality and timely clinical data delivery and database locks, train investigators/site coordinators/monitors at investigator meetings, maintain Novartis standards for database development, monitor CRO progress, and perform quality assurance review of CRO delivered study data.
Serve as Project Data Manager for multiple projects/studies from multiple therapeutic areas and provide professional data management (DM) input to Clinical Trial Teams (CTTs), study protocols, Study Specification Worksheets (SSW), and CRO selection. Participate in CRO audits and qualifications activities.
Lead and perform all aspects of data management related tasks for assigned in-house studies and ensure quality and timely completion of data management deliverables, including database lock, meeting KPIs and proactively maintaining study documents audit ready.
Responsible for ensuring consistency of protocols, project case reports forms (CRF), clinical databases for all studies within assigned projects and provide technical feedback internally or to CROs as needed.
Ensure complete and consistent medical term coding using appropriate standard dictionaries; ensure consistency of serious adverse event data across clinical and drug safety databases.
Monitor data quality and progress of trials both in-house and outsourced to CROs; drive corrective actions as needed; ensure proper integration of third-party/non-CRF data as applicable.
Proactively identify project threats and resolve issues with clinical trial teams; escalate to Biometrics management if necessary and appropriate.
Ensure timely archiving of data and data management documents; respond to Health Authority/FDA/Internal Audit requests pertaining to data management issues.
Provide input, review, and maintenance of local working practices and standards.
Contribute to the development of Data Management function within Biometrics. Lead and support clinical & non-clinical special projects.
Assist in hiring, coaching, training, and mentoring of other data managers, clinical trial leaders and CRAs.
Minimum requirements :
Bachelor's in life science, pharmacy, nursing, statistics, computer science or equivalent relevant training and experiences strongly preferred.
Ideally possess 5+ years’ of experience in drug development, with at least 4 years’ in data management of clinical studies preferred, including 2 or more years’ of experience in managing outsourced studies or working for a CRO.
Highly skilled in performing data management tasks using electronic data management systems, for example, RAVE, Inform, etc.
Very good with MS Excel; introductory level skills with SAS programming and SAS output.
Thorough understanding of physiology, drug development process, clinical trial methodology, GCP, medical terminology, and coding.
Good organizational and project management skills.
Innovative and good in technical and problem solving skills.
Ability to work independently and under pressure, demonstrating initiative and flexibility.
Good interpersonal, communication, and presentation skills and ability to operate effectively in matrix and an international environment.
Travel up to 10% of time may be required.