DeAnn Hyder

Experience

• 

  Quintiles

  Jan 1992 - Jan 1999

  Early Career

  • Clinical Project Manager on Internal Medicine/Endocrinology program, encompassing data management, biostatistics, and clinical monitoring; implemented process improvements to reduce data management project spending by nearly 50% (received Company Customer Service Award for accomplishments).• Administrative lead for multi-disciplined DM team, handling resourcing, project priorities.• DM Project Lead, managing design, edit check programming and validation, clinical data processes, budgets, timelines.• Clinical Data Reviewer, evaluating study data for accuracy, completeness, and logic Show less

• 

  IQVIA

  Apr 1999 - Jan 2005

  (Previously Quintiles)• Managed up to 20 Data Team Leads across customers, technologies and therapeutic areas, with oversight responsibility for up to 65 data management projects.• Provided expert review and guidance on Data Management deliverables including Data Management Plan, database set-up and validation, database transfers, project timelines.• Developed materials and trained department DM Leads on quality and financial checks, estimates at completion, evaluation of scope, creation of project plans.• Managed overall DM relationship with multiple customers. • Implemented and maintained customer DM metrics, monitored quality, efficiency, budgets and timelines across portfolios to identify trends as well as opportunities for improvements.• Developed and implemented customer-specific procedures to ensure consistency and quality across projects and global locations.• Represented DM at customer meetings, audits and vendor qualification audits• Contributed to DM functional budgets, proposals and contracts, change orders, staffing projections, DM plans and timelines, Requests for Information (RFIs).• Contributed data management expertise to SOPs, internal and customer audits, proposal meetings, task forces. • Managed transition of projects to other locations, including creation and implementation of project and customer-specific transition plans, coordination with leadership across offices, communication of transition plans with customers. Show less

  • Associate Director, Clinical Data Management (Previously Quintiles)

    Jan 2002 - Jan 2005

  • Manager, Clinical Data Management (Previously Quintiles)

    Apr 1999 - Mar 2002
• 

  IQVIA

  Jul 2005 - Apr 2021

  • Strategic Relationship/Account Head across customer portfolio of ~30 DM studies: Managed customer’s strategic Data Management goals for key partnership account; presented DM-related portfolio updates to global sponsor Biometrics and Clinical Development leaders; provided senior direction for ~75 Data Team Leads (DTLs), line managers, clinical data programmers (eDC and SAS) and operations team members across US, Europe, South Africa and India; collaborated with functional leadership peers to plan new study work (proposals, strategies, budgets, resources, timelines, deliverables); drove strategic initiatives, process improvements, new technologies, KPIs/KRIs• Served as 1st and 2nd line management, providing guidance to data team leads, Associate Directors and line mangers working across multiple studies, clients, indications and eDC platforms.• Partnered with other leaders in Global Clinical Data Management and affiliated functions to manage changing trial environments, improvements in processes, resourcing, training, quality, finances across DM. Show less (Previously Dir., Clinical Planning and Analytics, Therapeutic Science and Strategy with Quintiles)• Drove business interests and collaborated with IT and Data Scientists in developing innovative technical and analytical solutions supporting study planning, new offerings and operational insights.• Lead Lean Facilitator on study planning, patient recruitment and internal site management organization initiatives, and Faculty Advisor on 3 company-wide training sessions, mentoring global students across disciplines on projects and practical application of Lean principles.• Guided global teams and developed training on performing novel study meta-analyses; included data strategy, legal and data privacy considerations, thought leadership. • Received IQVIA Outstanding and Bravo Awards (2018) and IQVIA Silver Award (2019) for supporting partnership teams in cross-company process improvements and design (study planning, site identification, site management, vendor management).• Recognized by leadership for “extraordinary efforts and support towards the successful integration...” including process designs demonstrating new offerings, data and functional integration (2019). Show less • Founding member of cross-functional process optimization team reporting into CRO President; selected for clinical data management expertise, and initiative lead for process improvement and design efforts supporting data management, study feasibility, drug safety, clinical operations, project management, customer operations.• Developed risk-based data and site monitoring processes and prototype tools, including reduced SDV and Triggered Site Monitoring.• Developed methods, reported, and analyzed operational and enterprise data and metrics (Global Clinical Operations Scorecard, COO Scorecard, Chairman/CEO communications/presentations). Managed transition to global metrics and scorecard automation (including coordination among regional leaders, logic/specs for automation, communications, etc.).• Managed multifunctional team of initiative managers, statisticians and programmers on driving organizational improvements (2008-2010).• Collaborated with management team colleagues to develop and implement new department structure and focus 2010. Show less

  • Director, Clinical Data Management

    May 2020 - Apr 2021

  • Business Operations Director, Global Patient and Site Solutions

    Mar 2015 - Apr 2020

  • Director, Clinical Analytics and Simulations (Previously Quintiles)

    Sept 2013 - Feb 2015

  • Oper. Analytics Dir (2010-2013) / AD (2005-2010), Integrated Proc. and Tech. (Previously Quintiles)

    Jul 2005 - Aug 2013
• 

  Kronos Bio

  Apr 2021 - Mar 2024

  • Department head (2023-present): Develop DM strategy, standards, CRO oversight processes; mentor leads across studies and platforms; collaborate with peers to establish and improve cross-functional processes; develop budgets for DM, Biostatistics, DPO (Data Protection Officer) and Clinical Systems; manage hiring activities; manage relationships and share strategic needs with vendor partners; serve on Executive and Joint Operations teams with leadership peers and CRO team; present DM and Biostatistics functional and study needs to Executive Leadership Team • Lead DM efforts on multiple Clinical Development studies (Phase I and III Oncology), study launch through closeout: Coordinate, motivate and provide oversight of multiple CROs and other partners performing system builds (Veeva, Rave), capture, cleaning, integrations; drive study builds; perform hands-on UAT; manage database updates and decommissioning; develop internal DM oversight and quality plans; collaborate with Study Management Team peers to drive deliverables (DMCs, DEC Meetings, DSURs, IB Updates, publications, closeouts, etc.); support Clinical Trial Disclosure postings for ClinicalTrials.gov and EudraCT; manage DM and biostatistics finances (POs, invoices, change orders), timelines, scopes • Lead overall Study Management efforts for Phase I study in healthy volunteers from pre-database lock through CSR and eTMF closure (2022-present)• Provide expert review of regulatory documents (ICFs, CSRs, etc.) with special focus on data use and privacy; partner with IT on company-wide End-to-End data model, warehouse and tools; collaborate with peers to establish publication standards and data-related processes• Teach Clinical Development and Discovery Science teams about Clinical Data Management • Work with colleagues to establish new cross-functional systems (Veeva CDMS and Safety Vaults; IRT; Visualizations)• Develop trial data privacy notices with DPO partner and internal stakeholders Show less

  • Director, Clinical Data Management and Programming

    Jul 2023 - Mar 2024

  • Associate Director, Clinical Data Management and Programming

    Apr 2021 - Jun 2023
• 

  Ultragenyx

  May 2024 - now

  Senior Director, Clinical Data Management