With a shared mission to discover new ways to improve and extend people’s lives, our team of 120,000 global employees and our diverse portfolio of innovative medicines, eye care devices and cost-saving pharmaceuticals, we are addressing some of society’s most challenging healthcare issues. With our legacy deeply rooted in our Swiss heritage and with our eye on the future, our industry-leading pipeline, together with our continued investment in R&D and our high performing, diverse and passionate employees, we aim to be a trusted leader in changing the practice of medicine.
We are Novartis, and we are reimagining medicine.
This position ensure quality and timely clinical data delivery for multiple local studies including Phase IIIB/IV using appropriate application of data standards, monitor vendor progress, and perform quality assurance review of key clinical data management (CDM) deliverables.
Serve as Lead Data Manager for multiple projects/trials from multiple franchises and providing professional Data Management input to Clinical Trial Teams (CTTs). Responsible for ensuring consistency of protocols, project CRFs, clinical databases for all trials within assigned projects and provide technical feedback to CPOs as needed.
•Provide CDM input to study protocols and Study Specification Worksheets (SSW) for CPO proposal requests; provide input/create quotes. Develop CDM presentations for Investigator Meetings, CRA workshops, and Project Kick-off meetings, and Validation and Analysis Plans (VAPs) as appropriate.
•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 clinical data quality and progress of trials with CTS; 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 CTS management if necessary and appropriate.
•Ensure up-to-date and accurate tracking of report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases.
•Ensure timely completion of data management archiving; as necessary; respond to Health Authority/FDA/audit requests pertaining to project-specific data management issues.
•Provide input, review, and maintenance of local working practices and standards. Participate in the development of a Data Management organization through his/her leadership role within the DM Group for CTS.
•Participate in clinical & non-clinical special projects.
•May assist in hiring, coaching, training, and mentoring of other Data Management staff.
•University or college degree in life science, pharmacy, nursing statistics, biostatistics or equivalent relevant degree.
•Fluent English (oral and written)
•Ideally 4 or more years experience in drug development, with at least 3 years in Data Management activities.
•Experience in managing outsourced studies or working for a CRO.
•Understanding SAS output and introductory level skills with SAS.
•Thorough understanding of physiology, drug development process, clinical trial methodology, GCP, medical terminology, and coding.
•Project team leadership experience; good organizational and project management skills.
•Good technical and problem solving skills.
•Ability to work independently, under pressure, demonstrating initiative and flexibility. Attention to detail and quality focused.
•Good interpersonal and communication skills and ability to operate effectively in an international environment.
•Good negotiation skills. Ability to mentor, coach within Data Management and cross functionally, and train internal and external partners
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