Responsible for oversight and management of the operational aspects on assigned, ongoing projects and programs, in the oncology EBP portfolio, to ensure that all project work is completed. Principle duties include:- Managing and coordinating efforts of cross-functional project teams to ensure delivery of milestones and to manage, navigate and overcome study issues and obstacles. - Serving as the primary project contact with Sponsors, to ensure effective and timely communication is maintained and reporting schedules are followed. - Problem solving / resolution efforts, including risk management and successful mitigation strategies. - Developing, managing and maintaining a variety of study management plans.- Managing project budget, communicating scope changes and executing change orders with sponsors and study teams, to keep project delivery on track financially.

- Manages the execution of assigned clinical trial(s) and completion of study deliverables.- Develops, manages and reports on study timelines and metrics.- Supports development of vendor specifications & selection and management of external vendors.- Provides study-specific training to clinical research staff, Sponsor/CRO personnel, CRAs and other contract personnel. - Provides management, leadership and mentoring to CRAs.- Manages, plans, and directs the assignments and activities of the clinical team - Oversees the quality, quantity and timeliness of work performed by the clinical team.- Acts as liaison between sponsor and the clinical team to ensure clear communications

- Functional management oversight of clinical research aspects of multiple oncology trials,- Provided line-management oversight / support of CRAs- Primary point of contact for client´s clinical counterparts within a region (USA / globally)- Provided leadership and direction to project team members at a regional or global level.

Assessed quality, completeness and compliance with GCP, ICH and FDA guidelines for ex-US trial sites' central files, in preparation for regulatory submission.

Overall responsibility for insourced and outsourced Clinical Trial Monitoring activities for Merck clinical trials in the South Area of the US (OK, AR, TX, LA, MS, AL, GA and FL). Responsibilities included:-Strategic Management and Leadership - organizing, planning, setting and communicating accountable milestones for departmental area of responsibility. Collaborating with Therapy Area peers to deliver projects on time with adequate resources.- Financial Management of South Area (contractor budgets, FTE salaries, etc)- Staffing Management: performance management & staffing responsibilities for South Area, that included 7 CRA Managers (55 CRA direct reports), 1 CPM Manager (7 CPM/1 CTA direct reports) & 1 Clinical Trial Operations Manager (6 Sr Admin direct reports)

Overall responsibility for insourced clinical trials monitoring activities in the South Central Region of the US (OK, AR, TX, LA and MS). Responsibilities included:-Strategic Management and Leadership - organizing, planning, setting and communicating accountable milestones for departmental area of responsibility. Collaborating with Therapy Area peers to deliver projects on time with adequate resources.- Financial Management of South Central Region (contractor budgets, FTE salaries, etc)- Staffing Management: performance management & staffing responsibilities for South Central Region, that included 3 CRA Manager direct reports (w/ 28 CRA direct reports) & 1 Clinical Trial Operations Manager (4 Sr Admin direct reports).

A remote / field-based position with dual responsibilities for both CRA Management (8-10 Sr CRAs) and Project Management.

HMR sold division to Quintiles late 1998.