David Edghill Email & Phone Number

• Spearheaded the development of comprehensive Data Management Plans for small to medium biotech clinical studies.
• Led data quality through meticulous planning and adherence to Good Clinical Practice (GCP) standards.
• Expertly oversaw and selected Contract Research Organizations (CROs) to support study data management.
• Developed proficiency in Electronic Data Capture (EDC) systems for efficient data collection and analysis.

South San Francisco, California, US

• Therapeutic Areas: Oncology Solid Tumor| Immunotherapy
• Spearheaded all Clinical Data Management (CDM) planning, and operational activities within and outside of the organization providing long-term strategic leadership of the CDM unit supporting several drug development.
• Promoted to direct and oversee Clinical Data Managers (Full Time/Contractor) as well as Clinical SAS programmers (Contractor) in project support and deliverables.
• Established Biomarkers Data Transfer Agreement (DTA) process with external lab partners, CDM SOPs, and template in coordination with Pionyr QA, Bioanalytical, and IT for clinical study programs.
• Oversight CROs budgets (PPD and Advanced Clinical) (> 5 million) and vendors to ensure they are aligned with scope and compliance expectations based on outsourced studies and company objectives.
• Completed the successful Database lock of PY314 Part A (12/28/22), the first clinical database locked in the organization.

• Therapeutic Areas: Oncology Solid Tumor, Non-Hodgkin Lymphoma vaccine
• Shepherd all Clinical Data Management (CDM) planning and operational activities in relation to the company’s CMB305, G100 vaccine programs for various targets against solid tumors, and Non-Hodgkin’s Lymphoma Phase.
• Drove and evaluated new EDC clinical database platforms for the acquisition of Immune Design URL/Software license.
• Oversaw CROs (Medpace & Advanced Clinical) vendors to ensure they are aligned with scope and compliance expectations based on outsourced studies and company objectives.

• Therapeutic Areas: Oncology Solid Tumors, Lymphoid Malignancies, Acute Myeloid Leukemia
• Governed all Clinical Data Management (CDM), planning and operational activities for the company’s Antibody drug conjugates (ADC) programs for various targets against solid tumors, lymphoma and leukemia: Phase I/IB/II.
• Managed staffing of the CDM department and led the design implementation of clinical processes that aligned with parent company, Astellas Pharma US.
• Led vendor and technology bids evaluation, qualification, and selection of CRO partners.
• Oversaw CRO (Syneos & LabConnect) vendor to ensure they are aligned with scope and compliance expectations based on outsourced studies and company objectives.

South San Francisco, California, US

Therapeutic Area: Oncology Solid TumorsLed CDM study team and oversaw all build, conduct and close activities for one or more studies Phase I studies using data management strategies that yielded positive business results.

Los Angeles, CA, US

Therapeutic Experience: Oncology (Breast Cancer)Served as study Lead Data Manager responsible for Phase III study of Women with Early Stage HER-2 Breast Cancer Study (3,300 subjects/460 sites), with successful Medidata Rave database lock on March 6, 2015.

Therapeutic Area: Oncology Breast Cancer DeviceManaged data collection of 510K device and transfer process between clinical sites, CRAs, Sponsor and CRO, advising CRO to establish database build to closely match CDISC standards.

Master Of Science - Ms, Health Sciences And Clinical Research

B.A, Business Management/ Spanish