Greg Lessing Email & Phone Number

Wilmington, North Carolina, United States

Wilmington, North Carolina, United States

Serves as the Project Lead and primary sponsor contact. Accountable for the overall delivery of the project (quality, time, cost) on behalf of the organization. Establishes and communicates customer expectations to the project team with minimal direction. Ensures that escalation pathways are adhered to internally and externally. Leads the cross-functional project team to meet or exceed deliverables. Manages project of increasing complexity (such as but not limited to multi-service, Multi-region/country, therapeutic complexity, financial scope)

Wilmington, North Carolina, United States

Oversight of a portfolio of high complexity/high-profile, multi-center projects and the overall process of planning, scheduling and controlling the project from initiation to project closeout to ensure timely completion in a manner that is consistent with the Program Management role. This includes key elements of the following: Project/Program Management, Project Accounting, Stakeholder Management, Business Development/Commercial Awareness, Communication, Teamwork, Leadership, Client Management, Quality, Document ManagementRepresents program management on internal and external meetingsOptimization of program tools and practicesVerify that all project targets, timelines, budgets and requirements are met per scope of work and provide guidance to the project manager on each study on proper identification of changes in scope and communication of those changes with internal and external key stakeholdersEnsures compliance with all applicable government, corporate, and client policies, regulations, and standardsMaintains communications with other departments to ensure a cohesive and collaborative team approachDevelopment and review of project strategy, timelines, and budgets as part of proposal development and pre-award activitiesOversees and participates in the preparation and maintenance of study-related documentation. Examples of these documentation include, but are not limited to, bid defense materials, protocols, project management plans, procedural manuals, timelines, institutional review board documents, and project metric reportsProvides clients with regular study updates and communicate study progress to clients and in a responsible and professional mannerServes as a primary interface for the path of escalation with clients in managing performance concerns, prioritizes those concerns and ensures visibility, traction and resolutionBuild and maintain strong working relationships with clients, investigators, and research staff

Wilmington, North Carolina

Project Manager of 2 multi-national HIV & TB research programs encompassing 70+ protocols in 270 clinical research sites located in 22 countriesProject Management oversight of 130+ project team membersGlobal Resource Management. Ensure global resources are managed to ensure contracted services are achieved within stipulated level of effort and cost by using appropriate PM and Resource Management systemsDevelopment, implementation and maintenance of Procedural Documents including contract-specific SOPs and PWIs and Risk Management, Audit Readiness, Project Management, Training and Quality Management PlansRisk Management. Identify, track and manage (mitigate, accept, transfer or resolve) risks and opportunities within applicable project management systemsAudit Readiness. Compile and oversee execution of audit readiness plan Financial Management. Ensure contract execution within 2% of approved $20 Million+ budget. Conduct and oversee regional labor monitoring trip and financial forecasting. Review and approve monthly client invoices.Quality Management. Responsible for key quality indicators including report accuracy and timeliness, critical and non-critical quality event oversight and overall execution of contract SOW within the quality parameters stipulated in in the Quality Management Plan.Organize, develop presentation materials and host Quarterly Client Progress Review Meetings, Project Team Meetings, Management Team Meetings and Monthly Company/Client Leadership teleconferencesIdentify and manage out of scope activities through internal mitigation strategy and client escalation while maintaining a positive client relationship outlookParticipate in strategic business proposals development as writer or reviewer, contribute to budget development, resourcing strategy and ensure compliance with Federal Acquisition Regulations

Raleigh, North Carolina

-Manage all clinical operational and quality aspects to ensure compliance with 45 CFR 46, 21 CFR 321, ICH GCP E6(R2), country-specific regulations, client and PPD policies and procedures-Global client liaison. Evaluate requests from client against contract scope and execute where appropriate-Schedule and oversight to ensure monitoring visits (pre, during and post-visit activities) are conducted as described in the contract- Global resourcing to ensure contract obligations are achieved- Oversight of monitor and manager work assignments- Development and maintenance of site visit schedules- Resolve scheduling conflicts - Primary clinical management contact for Project Director, Project Manager and Monitors- Assist Project Manager with preparation of financial forecasts- Participate in strategic bid/proposal development as required- Participate in interview and recruitment process as required

Johannesburg Area, South Africa

- Site visit scheduling- Oversight for pre, during and post-visit activities for assigned sites within the EMEA and APAC regions including review and approval of pre-visit letters, work orders, record review tools and monitoring reports for client submission- Ensure reporting of critical events noted during monitoring visits within 24 hours- Manage all clinical operational and quality aspects to ensure compliance with 45 CFR 46, 21 CFR 321, ICH GCP E6(R2), country-specific regulations, client and PPD policies and procedures- Proficient knowledge and ensuring compliance with the contract as well as client and PPDs SOPs pertaining to the conduct of site initiation, interim monitoring, special assignment or closeout visits.

Johannesburg Area, South Africa

- Site visit scheduling- Oversight for pre, during and post-visit activities for assigned sites within the EMEA and APAC regions including review and approval of pre-visit letters, work orders, record review tools and monitoring reports for client submission- Ensure reporting of critical events noted during monitoring visits within 24 hours- Manage all clinical operational and quality aspects to ensure compliance with 45 CFR 46, 21 CFR 321, ICH GCP E6(R2), country-specific regulations, client and PPD policies and procedures- Proficient knowledge and ensuring compliance with the contract as well as client and PPDs SOPs pertaining to the conduct of site initiation, interim monitoring, special assignment or closeout visits.

Johannesburg Area, South Africa

Johannesburg Area, South Africa

Johannesburg Area, South Africa

Pretoria Area, South Africa