Jack Verga Email & Phone Number

Provide oversight of all aspects of data management from study start-up to database lock, including EDC design, data review/cleaning, query management, data reconciliation, and data transfer specifications.• Interfaces with study team, vendors, and sites to ensure that data management activities are performed consistently, and deliverables are of high-quality• Represents Data Management in study team meetings and facilitates cross-functional activities (e.g., clinical data listing reviews, database lock activities, etc.)• Ensures data management timelines and deliverables, including metric output, are detailed and communicated to the study team regularly• Provides oversight of external data providers and corresponding data reconciliation (e.g., IRT, safety, central and specialty labs, the patient-reported outcomes, etc.)• Provides oversight of data transfers and documentation of Data Transfer Plans for study• Authors, reviews, and/or approves various study-related documents and plans (e.g., Data Management Plans, eCRF Specifications, Edit Check Specifications, eCRF Completion Guidelines, Data Transfer Plans, etc.) and ensures records are maintained throughout the study• Participates and/or oversees database development (e.g., CRF development, edit check development, User Acceptance Testing, etc.)• Coordinates and/or provides training on data management systems, reporting tools, etc.• Contributes to preparation, conduct, and follow-up on Investigator Meetings• Participates in vendor selection and contract negotiation process, including RFPs and bid defense meetings• Participates in the development and maintains a working knowledge of study protocols and any amendments• Participates as subject matter expert during regulatory inspections and/or vendor audits• Contributes to the development of Data Management SOPs and Working Instructions, in addition to cross-functional SOPs

Provide oversight of all aspects of data management from study start-up to database lock, including EDC design, data review/cleaning, query management, data reconciliation, and data transfer specifications.• Interfaces with study team, vendors, and sites to ensure that data management activities are performed consistently, and deliverables are of high-quality• Represents Data Management in study team meetings and facilitates cross-functional activities (e.g., clinical data listing reviews, database lock activities, etc.)• Ensures data management timelines and deliverables, including metric output, are detailed and communicated to the study team regularly• Provides oversight of external data providers and corresponding data reconciliation (e.g., IRT, safety, central and specialty labs, the patient-reported outcomes, etc.)• Provides oversight of data transfers and documentation of Data Transfer Plans for study• Authors, reviews, and/or approves various study-related documents and plans (e.g., Data Management Plans, eCRF Specifications, Edit Check Specifications, eCRF Completion Guidelines, Data Transfer Plans, etc.) and ensures records are maintained throughout the study• Participates and/or oversees database development (e.g., CRF development, edit check development, User Acceptance Testing, etc.)• Coordinates and/or provides training on data management systems, reporting tools, etc.• Contributes to preparation, conduct, and follow-up on Investigator Meetings• Participates in vendor selection and contract negotiation process, including RFPs and bid defense meetings• Participates in the development and maintains a working knowledge of study protocols and any amendments• Participates as subject matter expert during regulatory inspections and/or vendor audits• Contributes to the development of Data Management SOPs and Working Instructions, in addition to cross-functional SOPs

Raleigh, North Carolina, United States

Provide leadership, direction, and operational oversight for Data Management operations. • Oversee data management activities across multiple projects, programs, and portfolios from study start-up through study closure• Serve as the cross-functional, sponsor, and vendor liaison to resolve escalations and ensure continuity among the project teams. Represent CDM group as a member of program governance team / joint operations committee. • Facilitate Project Review Meetings to ensure that timelines, resourcing, risk management, scope and budget, and quality of deliverables are maintained appropriately. Supervise proactive or corrective plans to improve quality or efficiency as appropriate.• Reviews financial / metrics reports for assigned projects, programs, and portfolios. • Monitor, forecast, and manage resource requirements for ongoing and future work. • Coach and train DM Project Managers in general team leadership skills, project management skills, internal Company processes, and for project specific tasks. • Line Management and operational support of assigned staff. Oversee professional development and training of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching. • Assist in driving recruitment of staff: Interview, onboard, and train new staff as appropriate. • Work with Business Development group to provide input to project budgets and scope of work for customer requested opportunities. Represent DM team at Business Development and Sponsor-related meetings. Participate in the RFP process including the evaluation of potential vendors.• Lead or participate in process improvement/departmental strategic initiatives to support the Business. This may include the development of departmental technologies, SOPs, processes and procedures.

Raleigh-Durham, North Carolina Area

Provided leadership, direction, and high-level expertise to the clinical data management group. Served as Centralized Resource Manager for North America • Worked across the sponsor account teams to evaluate resource utilization, capacity, and forecasted needs• Compiled and distributed various resourcing metrics reports to the department and to senior leadership • Served as the primary point of contact for interviewing and hiring in North America. • Maintained onboarding and orientation materials, and delivered new hires’ onboarding. Provided Line Management for up to 10 Direct Reports • Provided staff resources for project teams and ensured all activities were executed in a timely manner • Developed and mentored clinical data management staff to ensure high-quality work performance. • Recommended and implemented clinical data management performance and productivity improvements to ensure optimal use of billable staff. • Managed resources and resource projections to ensure project teams are consistent with client needs, expectations, and contractual obligations. • Participated in business development initiatives, including presentations and proposal development. • Performed metric collection and data analysis to improve policies, procedures, and business processes. • Represented the department on company, division, or department-level process improvement initiatives.

Regional (Home-Based), Usa

Embedded at Merck.Developed detailed, cross-functional project plans for the collection and validation of all clinical data for assigned trials within a specific drug/vaccine program. Served as Subject Matter Expert (SME) for MS Project (MSP) • Developed and maintained a process to streamline support opportunities between the SME group and the rest of the department, both on an individual basis and in open forum • Conducted virtual training sessions for team members that were onboarding or those who need orientation as new MSP functionalities are rolled out. • Trainings included basic functionality of MSP as well as the creation, linkage, and maintenance of project sub-schedules • Mentored team members as they encountered issues with their MSP schedules/sub-schedules • Authored/maintained MSP Job Aids, Process Documents, and Training Classes for the department Served as project manager over all data collection and validation activities from planning and initiation to execution, risk management, change control, and closure • Provided input into trial design, ensuring operational feasibility. Participated in vendor selection and supervised external data transfer documentation, programming, review and reconciliation.• Mapped out timelines for parallel functional builds (database, eCOA, IxRS, etc.) and met with functional leads to coordinate progress. Created and maintained integrated MSP schedules to monitor progress and generate status reports for senior leadership• Ensured timely archival of trial data and documentation and maintained inspection-ready TMF • Monitored overall status and quality of data collected during in-life • Accountable for activities required to achieve project closeout by responsible functional areas • Supported site and sponsor audits, as appropriate. • Identified and supported improvements to data collection and DM processes/tools

I provide leadership to the data management team (including programming, clinical coding, and data review) from project start-up through database close-out.Project Management Responsibilities:» Author/review/contribute to the development of the documents that make up the Data Management Plan in order to ensure that the project’s needs are accurately captured.» Periodically review: documentation filed into the eTMF in compliance with ICH/GCP/SOPs» Own the DM Risk Management Log, collaborating across functional teams to identify risks and plan avoidance or mitigation strategies.» Track the DM budget, analyzing work done vs. backlog and identifying risks and potential out of scope activities» When out of scope work is identified, I look for the most efficient means to effect the desired outcome and escalate the work through our Change Order process.Presentation experience (bid defenses, IMs, etc.). » This is a strength of mine. I was an academic and corporate educator/trainer in another life. Besides preparing me for presentation opportunities, this background informs how I establish rapport with internal and external customers, how I foster motivation toward common goals, and how I mentor team members.» I have successfully presented at many IMs, bid defenses, KOMs, etc. I have also performed project-specific training and served as SME for various applications and processes.Also Intrinsic to this role are the following tasks:» Function as the primary client interface representing data management» Manage multiple client projects simultaneously and maintain strong, long-term customer relationships» Lead Electronic Data Capture (EDC) development projects» Facilitate and lead requirements-gathering discussions» Coordinate data integration and reconciliation with third party vendors» Meet with team members on a regular basis regarding project tasks to ensure project milestones are met» Mentor junior Data Managers

Data Management (DM) Lead for multiple clinical trials, and occasionally provided support to other DM Leads. Composed and delivered numerous training presentations and process documents to ensure integrity in the conduct of project tasks across a portfolio of studies • Delivered trainings in classroom and online environments • Provided ongoing mentorship and served as SME for multiple processes Represented DM at internal and external meetings and presentations

• Coordinated the work of functional team leads to ensure deliverables were submitted according to defined budgets and timelines; Processed change orders when out-of-scope work became necessary • Served as back-up client interface representing project management • Maintained working risk management logs and timelines • Promoted open and proactive communication plans in order to control stakeholders’ expectations and mitigate risks• Produce and distribute status, tracking and financial reports for internal and external team members and senior management

Coordinated Data Adjudication Tasks involving collaboration between different functional teams • Streamlined cross-functional efforts between CDM and Clinical Operations departments • Adjudicated critical endpoint data: Conducted clinical review of critical data dossiers to ensure accurate data were captured from source documents. This saved significant time and money for the project. • Ensured that dossiers were accounted for, complete, and properly documented • Managed the distribution of dossiers to a third-party analytical committee Provided leadership for project team members on the conduct of various sub-tasks within the project Ensured the quality and integrity of clinical trial databases Reviewed data and resolved database discrepancies; queried study sites for data clarification Audited databases to ensure accurate data were captured from CRFs and DCFs Worked within ICH/GCP/FDA regulations, SOPs, work instructions, and study protocols

Ms, Biology, Behavioral Ecology

Activities and Societies: Sigma Xi, Animal Behavior Society

Bs, Biology Education, Psycology