Tucson, Arizona, United States
Clinical Data Management leader specializing in biometrics delivery, vendor oversight, and cross-functional leadership. Highly proficient in team management, clinical data standards (SDTM, CDASH), global data organization strategic support, and building team and client partnerships. Special interest in rare diseases, nervous system diseases, oncology, and precision medicine.
- Biometrics Lead for assigned programs/projects from initiation until the end of the project lifecycle and was accountable for all biometrics related project deliverables including programming, clinical data management, and biostatistics. - Functional lead for external CDx program with 20+ projects (including cinical utility/pivotal and method comparison studies). - Resolved, escalated, and triaged requests for issues that might impact project target dates, scope of work, or budget. - Analyzed and updated monthly/quarterly/ad hoc biometrics budgets for 30+ studies per study timelines/projected milestones and entered/tracked biometrics FTEs (estimated vs actuals). - Balanced multiple task assignments and communicated needs to the directors to obtain needed resources. - Represented Data Management in project related cross-functional study team meetings (internal and external), KOMs, RFIs, and site selection. - Developed, appraised, coached and counseled assigned staff. Assigned project work and regularly reviewed workload and compliance oversight for direct reports.
- Lead Data Manager for assigned CDx (companion diagnostic) programs for internal and external franchises with a combined average / total of 29+ studies. - LDM/Project Manager (DM) for multiple fast-paced data deliverables and timelines in collaboration with cross-functional team members and external vendors and clients. - Mentor/trained junior staff as needed and during study and/or program transitions. - Served as a Subject Matter Expert alongside Ventana Data Management counterparts for data, reporting, data transfer strategies and improvement and innovation as needed.
- CRO and vendor oversight in Data Management for all CNS clinical trials. - Served as the Sponsor Lead in clinical data management for three clinical trials (Phases IIb, III) and two start-up Phase II trials. - Worked closely with the Sr. Clinical Program Director and Study Managers to create tracking tools in JReview, assess vendor monitoring trends and quality and provide study metric reports to executives on-demand. - Attended and participated in RFP for data management, bid defense meetings, and kickoff meetings as head of data management function.