Jessica Hoang
Senior Director, Data Management, Oncology @Ascendis Pharma
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WORK HISTORY
Senior Director, Data Management, Oncology @Ascendis Pharma
Palo Alto, CA, US
Senior leader with accountability for the delivery of high-quality Clinical Data Management (CDM).Line manager of CDM staff, accountable for the recruitment, development, and succession planning of staff. Hands-on for study-level deliverables and provide training to staff as appropriate.An executive with overall responsibility for meeting the strategic aims, business case, and annual goals/objectives for both internal and external relationships for CDM.Focus on external alliance relationships via the governance bodies for strategic alliances where appropriate.Help drive and champion the Clinical Data Management Leadership Team strategy for CDM and collaborate with others across R&D to drive new holistic strategies across domain areas (e.g. Risk Based Monitoring, etc.).Lead significant levels of business change, within own organization and across the broader organization. This involves implementing and developing ground-breaking ways of working, to ensure we get the best value and standards of delivery through our people and external service providers.Regular contact with persons of influence and in decision-making positions within R&D to obtain desired outcomes while maintaining ongoing professional relationship.
EDUCATION
UC San Diego
Bachelor of Science (B.S.), Psychology
University of Phoenix
Master of Business Administration (MBA), Business Administration and Management, General
SKILLS
ABOUT JESSICA HOANG
As Head of Clinical Data Management (CDM)- Oncology at Ascendis Pharma, in the Sr. Director, Data Management - Oncology position, I am responsible for developing and implementing the strategic vision for the CDM group and overseeing all CDM activities from study start-up through close, reporting, and archiving to accelerate corporate drug development and optimize drug lifecycle management. I establish asset level strategies and tactics to ensure consistency, efficiency, and excellence in the application of standards, establishment of advanced, predictive data monitoring practices, and knowledge sharing. I am also responsible for building the CDM function with an effective resource model, efficient infrastructures and processes, and maintain an engaging and collaborative culture of excellence and high performance.CDMS EXPERIENCE:Medidata Rave®, Oracle Inform ®, OmniComm TrialMaster®, Medrio, iDataFax, SynCaptureTM, Veeva CDMS®SPECIALTIES:DM process and standards infrastructure and improvement, compliance and CAPA management, auditpreparation and execution, training, DM onboarding, EDC onboarding, vendor selection, ICH/GCP, GCDMP, 21 CFR Part 11, CDISC CDASH and SDTM standards.Extensive experience with CRO selection / CRO strategic partnership relationship and vendor management, protocol review, department budget development, MSA and contracting development, staffing requirement assessment, department goal development in alignment with corporate objectives, regulatory CDM compliance management, departmental DM SOP/guideline/technical document development, data trending/visualization and KPI development, study timeline and budget planning, CRF design, database development, database validation/UAT, data cleaning and quality control edit check specification, data review listing specifications, site management, external lab reconciliation, local lab management, medical coding, safety (SAE) reconciliation, and study start-up/conduct/closeout.Well-versed in the execution and oversight of data management activities, at the project level, for globalregulatory submissions and regulatory inspections.SUPERVISORY, MANAGEMENT AND LEADERSHIP EXPERIENCE:Management of direct reports, CDM consultants and CDM FSP contractors by coaching for performance, defining employee/manager roles and responsibilities, instilling trust, assisting in creating direction and alignment (goals and objectives), driving excellence, providing mentorship and guidance on career/skill development and technical industry knowledge, and performing HR administrative duties.
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