Wilmington, North Carolina, United States
• Over 33 years of experience within the pharmaceutical industry, 27 years in clinical research and clinical development experience. • Ability to direct complex projects from concept to fully operational status and study closure • Highly motivated yet easy going with a strong team and goal oriented problem solving mentality • Proven ability to work in unison with staff, Sr Management and others within the team Specialties: Phase I studies (PK/PD, first in man, combo safety studies) and Phase II trials in the US and Western Europe. Contract and budget negotiations, developing and presenting proposals and bid defenses, management of trials and client supervision and mentor monitors and junior PMs
I am a contributor to study specific documents (e.g., Protocols, ICFs, Pharmacy Manuals) for over 15 studies (both active and closed) I have provided scientific assessment for Operational Reviews of over 20 External Collaboration studies I have served as the primary clinical point of contact for over 20 studies, contributing and coordinating the resolution of scientific issues/questions for both internal and external business partners I have mentored two new ICON Clinical Scientists, focusing on the startup processes and procedures I have coordinated the review of data issues requiring clinical director input for over 15 External Collaboration studies I have reviewed over 20 informed consent forms (both initial and updates) employing the Merck checklist and garnering ICF Managerial approvals I have collaboratively planned and executed over 9 CSR reviews with the Clinical Directors and other CSR reviewers within Merck I have led over 20 studies and am accountable for the clinical/scientific review, obtaining approvals and execution of the protocols. I am responsible for coordinating with the Clinical Directors, Biostats, Biomarkers Lead, Safety and Regulatory the trial design and endpoint development to coordinate governance committee review I have supported multiple Joint Development Committee (JDC) adjudication committees
• Develop, coordinate, and implement research and administrative strategies essential to the successful management of phase II, III and IV clinical trials research projects conducted by principal investigator(s) at Duke University Medical Center; perform a variety of duties involved in the organization, documentation and compilation of clinical research data; function in preceptor capacity for Clinical trials Project Leader I’s and II’s • Develop systems for the establishment and refinement of guidelines in the collection of clinical data and administration of clinical trials; design and evaluate alternative methodology as necessary. • Advise and assist principal investigator and other team members in the development of plans, time lines, and processes for clinical research studies; coordinate the ongoing analysis and modification of protocols; recommend amendments to study protocols as appropriate. • Confer with site coordinators and physicians to explain protocol and to elicit compliance with regulations; assure adherence to Federal Drug Administration and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate. • Coordinate and lead the work of the Project Leader I and II staff and research team and provide feedback to staff’s supervisor on a routine basis; conduct cross functional research team meetings as needed. Advise and assist the principal investigator in initial contacts and development of relationships with outside partners and internal functional groups for potential projects including trial budget and contract negotiations. Perform other related duties incidental to the work described herein.
• Drive the operational implementation of the alliance strategy. • Oversee delivery of alliance program work. • Manage INCR project teams. • Plan and negotiate resources across program of work with line management of various functional areas. • Provide direct-line management and professional development to a team of project managers, clinical research associates, and project management research associates. • Lead preparation of Customer-requested proposals and budgets. • Serve as the primary liaison between INCR and the customer to ensure study launch, conduct and closeout according to the Customer’s and INCR’s contractual agreements. • Ensure study progression according to internal and Customer quality standards, SOPs, GCPs, and ICH guidelines
Serve as the primary contact and liaison for the clinical team and manage clinical studies for the development of OPDC drugs. Interact with expert physicians, investigators, vendor/CRO personnel, and functional area staff to ensure that the clinical program is run according to ICH, FDA, and OPDC guidelines. Ensure compliance with FDA and international regulations, GCPs, and SOPs.
• Serve as the operational lead for assigned projects. • Contribute to the development and implementation of study strategy • Serve as primary contact for protocol related issues and oversee the conduct of day-to-day operations • Review and analyze the data from tables and listings. • Contribute to Clinical Study Reports. • Serve as a resource to the ESP and study team to identify problems and propose solutions to maintain projects within designated timelines and budgets. • Responsible for the quality of the preparation, presentation, issue identification, and follow-up for all portions of investigator meetings, if applicable. • Identify and escalates potential serious compliance issues, and assist in the development of action plans. • Ensure that assigned studies are conducted following the protocol, ICH, GCP and all applicable global regulatory requirements. • Review and approve Oversight Reports; familiar with trends from oversight and ESP trip reports. • Ensure smooth communication and interaction within project team. • Participate in process and continuous improvement initiatives as assigned
• Manage several interdisciplinary clinical research projects (Phase I and II with some experience in Phase III), as Project Manager, leading the clinical team to ensure on time, in scope and within budget performance • Supervise, train and mentor Clinical Research staff • Approve Investigator study budgets and contracts • Review and approve regulatory and administrative documents from investigator sites • Participate in both the preparation and presentation of proposal meetings with potential clients