Gabriel Martinez

Knowledgeable leader adept at planning, directing and maintaining global clinical trials operations. Experienced at managing trials from study start-up, interacting with vendors, regulatory and ethics committees, IRBs, and other regulatory bodies. Skilled at identifying or anticipating problems and providing solutions.

• Intellia Therapeutics, Project Manager, 01/01/24, Present
• Regeneron Therapeutics, Project Manager, 11/01/22, 07/01/23
• Spark Therapeutics, Project Manager, 06/01/22, 12/01/22
• Ultragenyx, Program Manager, 03/01/19, 06/01/22
• Tista Science, Program Manager, 07/01/17, 11/01/18
• Engility Corporation, Program Manager, 11/01/16, 06/01/17
• UCSD Hospital, Project Manager, 05/01/16, 10/01/16
• Molina Healthcare, Project Manager, 10/01/14, 01/01/16
• Genoptix, Project Manager, 10/01/13, 10/01/14
• Molina Healthcare, Project Manager, 03/01/12, 10/01/13
• PWC, Manager, 10/01/10, 02/01/12

• Participated in study start-up and close-out activities at Genoptix/ NeoGenomics.
• Managed all clinical trial startup activities for Genoptix/NeoGenomics, including sample tracking, access request forms, patient authorization forms, development of specimen collection kit, LIMS system entry, accessioning, IVR management, reporting on test results, data transmissions, or direct data entry into the CRF or EDC based on study requirements.
• Created and built relationships with BioPharma clinical study teams. Developed and facilitated the budget and proposal process/agreements for Biotech clients.
• Managed the development and delivery of CRA training video, SIV, site user guide, subject user guide, access request form, tracking of shipments, startup instructions.
• Reviewed and approved invoices for clinical testing and study activities.
• Reviewed and adhered to clinical trials contracts, data transfer agreements, master service agreements, and work orders.
• Led clinical trial kick-off meetings with clinical trial study sites, and logistics stakeholders.
• Developed and managed specimen collection manual, test requisition form, study requirements, and site initiation visit presentations.
• Authored and updated internal controlled documents, specimen collection kits, SOPs, work instructions, and training aids.
• Built and maintained relationships with clinical, study, outsourcing, and project teams at Pharma companies to obtain, promote, and manage projects.
• Researched and resolved project-related issues independently.
• Initiated and managed the proposal process for assigned clients.
• Prepared proposals, contracts, and client presentations.
• Independently developed project budgets and scopes.
• Generated pricing for projects and managed contracts through the legal process to execution.
• Worked in conjunction with internal finance and legal teams as required to write proposals, facilitate agreements (e.g., negotiate pricing), and maintain revenue forecasts.
• Developed, managed, and executed assigned projects.
• Worked in conjunction with sponsors, project leaders, principal investigators, clinical and outsourcing groups to develop plans, define roles, responsibilities, and scope of work, and for research and resolution of related issues.
• Oversaw and managed assigned project staff (as applicable) to ensure timely and accurate completion of project milestones.
• Monitored project status and provided regular updates to management, governance teams, and sponsors.
• Ensured the timeliness of all billing activities for assigned projects.
• Served as department representative at study meetings with external Pharma companies.
• Reviewed, developed, implemented, and identified ongoing opportunities for efficiencies and quality as they relate to billing, forecasting, project management, etc.
• Worked in conjunction with the marketing department to design, develop, and utilize marketing tools for department-specific projects.
• Prepared pitch presentations for client presentations and co-presented to prospective clients and current clients on capabilities.

• ALCOA+
• FDA regulations
• ISO 14155:2020
• GAMP 5
• 21 CFR Part 11
• ICH E3
• Nugenesis Waters SDMS
• Labware
• LabVantage

• PMP, Project Management Professional, Lic. 1723533, 08/01/15
• CSM, Certified Scrum Master, Lic. 000237784, 02/01/13