Jacob King
Fuquay-Varina,NC
Summary
Award-winning, results-driven, and dynamic clinical research leader with 13+ years of experience in global phase I-IV trials across diverse therapeutic areas. Proven ICH/GCP expertise in Clinical Operations and Data Management, demonstrated within cross-functional team management and strategic portfolio leadership; oversight of DM Departmental milestones met or exceeded in study build/go-live, postproduction, and database lock. Strong understanding of industry trends, strategy, and regulatory requirements. Adept at CRO oversight, budget optimization, risk management, and innovation with a strong focus on patient-centric design, data integrity, and encouraging collaboration/stakeholder engagement that accelerates pipeline advancement while strengthening organizational growth.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Associate Director, Head of Data Management
Evestia Clinical (Formerly Bionical Emas/EMAS Pharma)
09.2023 - Current
- Support the Executive VP of Clinical Development
- Define and lead Data Management, Data Science & Analytics functions.
- Ensure all global Data Management operations and projects are delivered from the proposal stage to completion.
- Lead/support the development of Data Science & Analytics and company-wide processes and improvements.
- Lead/support the selection and implementation of Data Management and company systems.
- Contribute to the development and delivery of KPIs and relevant metrics.
- Act as an expert in the business on behalf of Data Science & Analytics and provide senior consultation within Data Management and/or to clients.
- Provide line management and supervision of Data Science & Analytics staff.
- Support business development activities and contribute to the development and growth of business opportunities: lead/contribute to the development of proposals and associated costings; input into standard cost models; prepare and attend bid defenses; and contribute to the development of marketing materials, including journal publications, conference abstracts, and posters.
- Perform or supervise database setup and amendment activities to ensure the release of quality databases according to sponsors’ expectations, study budgets, clinical trial documentation, and timelines.
- Liaise with programmers and/or statisticians to ensure correct study design and data extract mapping.
- Review protocol amendments, perform impact and risk assessment for clinical databases, and ensure any updates are agreed and performed within approved timelines.
- Create and maintain a standard CDASH / eCRF library with associated processes and controls.
- Create and maintain standard study dashboards & reports with associated processes and controls.
- Support with any other reasonable task as approved by the Executive VP of Clinical Development
- Line manage, develop, and provide leadership for direct reports and conduct performance reviews and one-to-one meetings.
- Ensure direct reports are aware of their assigned responsibilities via Job Description and objectives.
- Liaise with HR when recruiting new employees and ensure that the current content version of the job is up-to-date. Description is provided and managed by HR.
- Raise any issues in content, including the requirement for a new Job Description, with the Senior Function Manager and Training.
- Create and maintain relevant SOPs.
- Train, coach, and mentor Clinical Data Associates, Clinical Data Managers, and Senior Clinical Data Managers.
- Proactively create/ update training materials for Clinical Data Managers.
- Define and deliver training workshops or presentations within and across Clinical Development, including the proactive management of training materials.
- Actively promote and represent Bionical-Emas via attendance at meetings and conferences, and as appropriate, become a member/involved with professional associations.
- Improve the effectiveness of the organization by taking a lead role in, and contributing to, company-level processes and technical improvement efforts.
- Prepare for, participate in, and respond to capability, internal, and external audits.
- Responsible person for the resolution of assigned Corrective or Preventive Actions (CAPA).
- Assist and act as deputy for Line Manager or Senior Management Team as appropriate.
- Provide input to project proposals and take part in bid defense meetings as required.
- Line manage, develop, and provide leadership for direct reports and conduct performance reviews and one-to-one meetings.
- Ensure timely and accurate entry of information in the time recording system.
- Manage project budgets and scope, conducting frequent project reviews to ensure profitability is maximized and provide management information.
- Engage with customers to ensure a positive and stress-free customer and site experience via a consultative and risk management approach.
- Keep abreast of project status and ensure delivery requirements and deadlines are precise and achieved via frequent communication with project teams.
- Lead, encourage, and support cross-functional project teams to deliver to requirements, budget, and deadlines.
- Communicate frequently and responsively with customers and clinical partners regarding timelines, requirements, and scope, providing formal status updates and instigating frequent and proactive contact.
- Forecast, manage, and adjust resources required to meet project deadlines and invoicing milestones.
- Lead project kick-off meetings, establishing clarity of customer requirements and project plans, providing expert guidance to customers throughout the set-up phase.
- Escalate significant issues promptly to senior management and/or account management.
- Coordinate project requirements with clinical partners and third-party vendors
- Share EDC expertise with project teams, customers, sites, and other users.
- Identify, mitigate, and monitor project risks, proactively identify improvements, and solve problems or instigate solutions using a logical and systematic approach.
- Conduct project lessons learned reviews at appropriate stages in projects and ensure actions are addressed.
- Assist business development activities via expert technical input (e.g., bid defense meetings)
- Represent the department in audits, where required.
- Perform other reasonable tasks as requested by management.
Team Lead, Customer Enablement
Medrio
07.2022 - 09.2023
- Serve as the department lead for "Customer Enablement Coordination" while ensuring quality processes and documentation are available / utilized for each client engagement.
- Supervise the team supporting clients during their initial interaction with Medrio software and services by understanding customer business goals and objectives, developing strong rapport, and executing against a defined training plan.
- Play a pivotal role in the initial training, project management, and delivery of implementation and integration of Medrio services.
- Managing a portfolio of customer and site enablement projects with a diverse set of customers and therapeutic indications; aligning Medrio best practices with industry data management processes/workflow while instilling guided autonomy.
- Serve as the first touch point in a customer’s experience post-sale; a critical player in driving long-term customer success and demonstrating the value of the Medrio solution.
- Working across departments, including Sales, Customer Success, Professional Services, Data Sciences, Engineering, and Product Management, bringing customer objectives to fruition through cross-departmental collaboration and communication.
- Manage activities of Customer Enablement Managers
- Lead, coach, and empower the Enablement team to be successful in their roles.
- Create an engagement model for low-tech touch accounts.
- Manage and update processes relating to the day-to-day job function of the CEM.
- Recruit and train new staff as needed following standard protocols defined in SOPs.
- Monitor and report on team activities, including providing case audit results and case escalations.
- Coordinate communication with customers on case escalations or outstanding issues
- Partner with cross-functional teams to equip Specialist teams.
- Collaborate with internal product designers to prioritize customer feature requests.
- Manage a portfolio of key customer relationships.
- Foster a positive team culture.
Customer Enablement Manager
Medrio
11.2021 - 07.2022
- Play a pivotal role in the initial training, project management, and delivery of implementation and integration of Medrio services.
- Managing a portfolio of customer and site enablement projects with a diverse set of customers and therapeutic indications; aligning Medrio best practices with industry data management processes/workflow while instilling guided autonomy.
- Serve as the first touch point in a customer’s experience post-sale, will be a critical player in driving long-term customer success, and will demonstrate the value of the Medrio solution.
- Working across departments, including Sales, Customer Success, Professional Services, Data Sciences, Engineering, and Product Management, bringing customer objectives to fruition through cross-departmental collaboration and communication.
- Create an engagement model for low-tech touch accounts.
- Manage and update processes relating to the day-to-day job function of the CEM.
- Monitor and report on team activities, including providing case audit results and case escalations.
- Coordinate communication with customers on case escalations or outstanding issues
- Partner with cross-functional teams to equip Specialist teams.
- Collaborate with internal product designers to prioritize customer feature requests.
Data Management Project Manager
Medsource (Now Ergomed)
11.2019 - 11.2021
- Manage project budgets and scope, conducting frequent project reviews to ensure profitability is maximized and provide management information.
- Engage with customers to ensure a positive and stress-free customer and site experience via a consultative and risk management approach.
- Keep abreast of project status and ensure delivery requirements and deadlines are precise and achieved via frequent communication with project teams.
- Lead, encourage, and support cross-functional project teams to deliver to requirements, budget, and deadlines.
- Communicate frequently and responsively with customers and clinical partners regarding timelines, requirements, and scope, providing formal status updates and instigating frequent and proactive contact.
- Forecast, manage, and adjust resources required to meet project deadlines and invoicing milestones.
- Lead project kick-off meetings, establishing clarity of customer requirements and project plans, providing expert guidance to customers throughout the set-up phase.
- Escalate significant issues promptly to senior management and/or account management.
- Coordinate project requirements with clinical partners and third-party vendors
- Share EDC expertise with project teams, customers, sites, and other users.
- Identify, mitigate, and monitor project risks, proactively identify improvements, and solve problems or instigate solutions using a logical and systematic approach.
- Conduct project lessons learned reviews at appropriate stages in projects and ensure actions are addressed.
- Assist business development activities via expert technical input (e.g., bid defense meetings)
- Represent the department in audits, where required.
- Perform other reasonable tasks as requested by management.
Lead Data Manager
Pharm-Olam International
06.2017 - 11.2019
- Accountable for the quality of work performed in conjunction with the Pharm-Olam Data Project Manager (DPM)
- Assist in the preparation of Data Management process control documents, including but not limited to Data Management Plan, Data Quality Rules Specification, Data Transfers Agreements/Specifications, Database Build specifications, Edit Check creation, Database Mid Study Updates, and Database Interim Analysis/Lock.
- Assist Data Project Managers in creating, reviewing, and finalizing Case Report Forms (CRFs)
- Responsible for the set-up of all study information on the database and supporting the development of DM control documents
- Generate predefined listings and conduct reviews of data listings under the guidance of the Data Project Manager (DPM)
- Support the Data Project Manager (DPM) in the effective management of all data management aspects of assigned project(s) from setup.
- Under supervision from the Data Project Manager (DPM), assist in database(s) testing, identify database errors, and report them to the Data Systems Designer, following through to resolution.
- Process/clean data, including data entry, ensuring consistency, accuracy, and completeness of the database via query management/resolve.
- Support data review, including reconciliation of SAEs, Labs, Vendor data, etc.
- Work in strict adherence to SOPs, as well as current ICH-GCP guidelines and other applicable standards demanded by the Regulatory Authorities
- Responsible for training multiple global study team members, site, and Sponsor personnel
In-House Monitor (CRA) | Feasibility | Study Start-up
Pharm-Olam International
04.2016 - 06.2017
- Performs as an in-house CRA, core team member, and in-house support for the clinical team while coordinating site start-up operations.
- Leads activities in local feasibility and site identification.
- Perform selected on-site visits and/or site management activities to assist the field monitors, as required.
- Collaborate with project team to ensure site start-up activities are completed within project timelines and in accordance with all applicable regulations, guidelines, and Standard Operating Procedures (SOPs)
- Forecast, manage, and adjust resources required to meet project deadlines and invoicing milestones.
- Lead project kick-off meetings, establishing clarity of customer requirements and project plans, providing expert guidance to customers throughout the set-up phase.
- Escalate significant issues promptly to senior management and/or account management.
- Coordinate project requirements with clinical partners and third-party vendors
- Share EDC expertise with project teams, customers, sites, and other users.
- Identify, mitigate, and monitor project risks, proactively identify improvements, and solve problems or instigate solutions using a logical and systematic approach.
- Conduct project lessons learned reviews at appropriate stages in projects and ensure actions are addressed.
- Assist business development activities via expert technical input (e.g., bid defense meetings)
- Represent the department in audits, where required.
- Perform other reasonable tasks as requested by management.
Project Management Analyst
Quintiles (Now IQVIA)
08.2015 - 04.2016
- Collaborate with Project Manager, Clinical Lead, Project Integration Manager, and Lead Clinical Analyst to monitor and execute a wide array of project management responsibilities within international, multi-center trials.
- Proactively monitor study performance via internal and/or customer systems to manage all study costs, change orders, and study risks while ensuring accurate and timely submission of all global study tasks.
- Processing monthly study financials, initiating study file review/audits, study communications, study timeline oversight, study metric analysis, and managing overall study reports/trends.
- Serve as a back-up contact for both internal project teams and external customers designated by the project manager.
Education
EMT-B - undefined
Wake Tech Community College
Raleigh, NC01.2014
BA - Criminology
North Carolina State University
Raleigh, NC01.2008
Skills
- Change Management & Organizational Oversight
- Cross-Functional Team Leadership
- ICH-GCP Standards
- 21 CFR Part 11 Compliance
- MHRA, FDA, EMA, Health Canada Regulations
- Inspection Management
- Audit Readiness
- FDA Audit
- MHRA Inspection
- Bid Defense
- Conflict Resolution & Negotiation
- Executive-Level Communication
- Risk Assessment & Decision Making
- KPI Metric Expertise
- Data Integrity & Analysis
- Data Analysis
- SQL
- AI Implementation
- EPRO
- EConsent
- Global Clinical Trials
- CTMS
- CRO Management
- SOP/ WI Development
- EDC Platforms: Zetta, Veeva, RAVE, Medrio
- Database Validation / Qualification
- Clinical Monitoring
- Database Go-Live
- Database Lock
- Clinical Trial Project Management
- ECRF Development
- Rare Disease
Websites
Certification
NCEMT-B Certification: License 100743 (Inactive) 2014-2018
Accomplishments
Recognized for expert level data analysis within multiple datasets; authored department level dashboards for decision making metrics that met or exceeded execution of study deliverables.
Languages
English
Native or Bilingual
Timeline
Associate Director, Head of Data Management
Evestia Clinical (Formerly Bionical Emas/EMAS Pharma)
09.2023 - Current
Team Lead, Customer Enablement
Medrio
07.2022 - 09.2023
Customer Enablement Manager
Medrio
11.2021 - 07.2022
Data Management Project Manager
Medsource (Now Ergomed)
11.2019 - 11.2021
Lead Data Manager
Pharm-Olam International
06.2017 - 11.2019
In-House Monitor (CRA) | Feasibility | Study Start-up
Pharm-Olam International
04.2016 - 06.2017
Project Management Analyst
Quintiles (Now IQVIA)
08.2015 - 04.2016
EMT-B - undefined
Wake Tech Community College
BA - Criminology
North Carolina State University