Consultant for the pharmaceutical and biotech industry, providing program & project management, operations, and medical writing services to international and domestic sponsor organizations.

- Asses gaps and road blocks in business operations and compliance- Identify and onboard vendors to fill gaps and optimize workflows- Analyze financial data to reduce costs and improve efficiency- Perform Human Resource functions - Oversee Safety Training implementation

• Oversee program operations to include delivery of integrated program plans and schematics, risk registers, and contractual reporting deliverables to meet program goals; and recommend revisions as appropriate to meet changing needs and requirements.• Work with cross-functional project and program teams to identify and address constraints to achieve project and program deliverables, timelines, and budgets in fulfillment of corporate objectives. • Monitor and manage the contractual, technical, and financial requirements and deliverables for each project/program, working closely with the Contracts, Finance, and technical leads.• Establish program management best practices and assist in the implementation of infrastructure necessary for successful program management.• Maintain frequent communications with enterprise-wide program teams and key internal stakeholders so that all parties are aware of current strategies, plans and business needs, interdependencies, critical path activities, issues, contingencies, and milestones. • Drive timely decisions and facilitate active communication and information flow among teams, development and commercialization functions and governance bodies.

Consultant for the pharmaceutical and biotech industry, providing program & project management, operations, and medical writing services to international and domestic sponsor organizations. o Recognized for leadership skills in complex problem-solving and scientific teamwork.o Effectively selected and managed a variety of clinical operations vendors.o Oversaw the first on-time clinical trial in a Japanese client-partner’s history despite an unanticipated regulatory agency shut-down.o Facilitated close collaboration with rare-disease patient advocacy group.o Contributed to regulatory strategy and submissions for FDA, EMA, South Africa, Australia and Chile.

• Provide operational oversight for a large, $8.5 million, investigator-initiated, U.S. multi-center, Phase III pragmatic clinical trial in pediatric Crohn's disease.• Coordinate effective communications and work effort across a multi-site, multidisciplinary research team, including an academic site and data coordinating center, a placebo manufacturer, a central investigational drug services pharmacy, three central laboratories, a data safety monitoring board, and a variety of stakeholder groups.• Co-developed the study protocol, amendments, informed consent templates, recruitment materials, central IRB submission documents, case reports forms, and training materials.• Organize and deliver training for study-site staff.• Negotiate the scope of work and budget for the placebo manufacturer and central investigational drug pharmacy.• Complete periodic written progress reports for study funders.

• Performed study start-up activities for the UNC Kidney Center including contract review, budget development and negotiation, IRB submissions, and regulatory document completion and filing.• Co-developed a study budget template that streamlined and standardized the budget development process.

• Revitalized a strategy for delivering a life skill based behavior change and HIV prevention curriculum in impoverished township schools.• Built local capacity by recruiting, training, and providing hands-on mentoring to more than 30 volunteer educators and over 250 public school educators.• Developed a partnership with, and secured funding from, the Department of Education to conduct multiple training seminars for public school educators and community-based volunteers.• Designed program and curriculum enhancements to make the strategy more culturally appropriate.• Devised a survey instrument to measure effectiveness of the strategy.

• Created and maintained an aggressive timeline to achieve a clean database for a large-scale, international, safety and efficacy study. • Worked with colleagues to finalize study closeout activities and prepare for a European Dossier submission.• Assessed and initiated corrections of discrepancies in safety data and compiled protocol deviation data for development of the clinical study report.• Reviewed cross-departmental written Standard Operating Procedures (SOPs) via team meetings, teleconferences, and e-meetings.• Evaluated work processes and procedures in order to improve overall operational efficiency.

• Assigned to a highly visible, fast track clinical program requiring new protocol and process development, large-scale outsourcing, and intensive team collaboration. • Implemented a $16 million dollar, Phase III study across 8 Asian countries.• Led a global, interdisciplinary study team of over 25 people, resulting in an on-time study start, recruitment of over 3000 subjects in 6 weeks, and minimal audit findings.• Developed protocols and amendments, informed consent templates, and case report forms (CRFs). • Negotiated contracts and budgets for the contract research organization (CRO), interactive voice response system (IVRS), courier, and investigators.• Co-developed and delivered training for CRO, central laboratory, company-affiliate, and study-site staff.• Provided oversight for contracted activities, timelines, and budgets, including periodic face-to-face visits with CRO and study sites.• Presented at global clinical team and project management meetings.

• Responsible for planning, executing, and closing out Phase I and II clinical studies. Acted as a Lead CRA on multiple studies, working on as many as 6 studies concurrently.• Assigned to “clean up” problem study sites and to wrap up loose ends on stagnant projects.• Assisted with site identification and evaluation, negotiated investigator budgets, collected and reviewed regulatory documents, developed case report forms and training materials, conducted study initiation meetings, coordinated study supplies, performed source document verification of trial data, and identified and resolved data queries with trial sites.