Provides day-to-day leadership, strategic direction and supervision to Clinical Monitoring staff. Oversees the clinical monitoring process and strategic project contribution, combined with management of the CM team makes a critical contribution to the overall success in the delivery of clinical services for Veristat projects. Participates in the development and implementation of operational strategies, policies and procedures for the CM Department, and ensures project deliverables meet client expectations. Also oversees Key Performance Indicators and metrics related to the CM function, thereby ensuring the quality of each clinical trial quality, and ensuring that trials are being conducted in compliance with applicable regulations, SOPs, GCPs, and ICH guidelines. Accountable for multiple projects/clients and managing client relationships and expectations, and delivering results. Maintains a proactive, positive, results-oriented work environment.

Line manager for 20+ regional CRAs effectively, ensuring high performance, quality of monitoring and continuous development. Ensure appropriate issue escalation of quality findings. Provide feedback on the development CRA training tools. Conduct CRA performance reviews and make recommendations for promotions. Conduct regular CRA group meetings to provide timely and relevant updates. Interview, evaluate and select new CRA hires. Oversee induction and orientation for newly hired CRAs. Ensure CRAs are meeting performance objectives and take appropriate remedial actions as required. Mentor and train new employees in the IHCRA to CRA program.

Day-to-day management and operational delivery of clinical trials including site selection, start-up, enrollment management, site engagement, monitoring planning and execution, data cleaning activities and close-out. Work in close collaboration with other functional team members. Identify and develop CRA training needs. Identify and mitigate potential risks to enrollment targets. Oversee third-party vendors. Tracking and reviewing overall progress of studies. Oversee quality of site performance

Line management of CTAs and CTMsMonitor and evaluate performanceOrganize and direct training of ClinOps teamProvide site support: recruitment, initiation, payments, close-out, etcProvide oversight of clinical trials

Line management of CTAs and CTCsAssignment of resources and projectsMonitor and evaluate performanceOrganize and direct trainingImplement quality systemsFollow-up and resolve audit findings

In this role, I was promoted following the merger between Glaxo and Smith Kline to spearhead and integrate a centralized CRF development team. I hired, trained, supervised and developed the talents of ten associates. I coordinated with medical affairs and other teams to harmonize processes and practices, thereby improving the accuracy, quality, database compatibility and speed of CRF design and development. I also liaised with key customers to allocate resources, meet timelines and achieve operational objectives.► Successfully streamlined the CRF development process by combining the technical writing and the graphic design process, which reduced the need for four contracted resources. ► Improved overall quality of CRFs as evidenced by fewer rounds of revisions and corrections.

In this role, I was recruited and selected to serve as the international project manager for three pivotal malaria studies. I oversaw the study master file, kick-off, investigator meeting coordination, regulatory document collection, study drug supply coordination, site budgets and monitoring for five countries (France, Germany, Denmark, the Netherlands and the UK). I managed, scheduled and trained up to 15 CRAs. I also ensured regulatory compliance from site initiation through study close and submission of study reports.► Wrote the IND annual report which led to FDA approval of a new formulation of the drug, which has since become the global standard for Malaria prevention.► Developed and delivered training sessions at five investigator meetings (one per country).► Utilized and developed strategies which significantly improved communication and coordination across geographical, cultural and language barriers at sites.

I was recruited to this role to manage, train and mentor teams of up to eight regional CRAs within a matrixed organization structure. I served as the liaison between CRAs and Project Management with overall responsibility for developing and executing monitoring plans and compiling data within study timelines. I performed quality assurance to meet all GCP and regulatory standards and comply with company SOPs.► Played a key role in rescuing and completing a Schizophrenia trial by resolving critical site issues related to regulatory documents, drug inventory monitoring, data management and other issues.► Consistently achieved monitoring quality targets and timelines within budgets.

In this role, I provided a clinical perspective and input ranging from product development to marketing in support of a Swedish-owned start-up company pioneering hand-held electronic patient diaries. I trained a team of 15 on all aspects of clinical research and GCP. I also assisted in designing diaries and eCRFs and wrote training materials for investigative sites.► Expanded role to include product testing, thereby identifying key issues and recommending improvements to drive adoption of the technology at sites.

In this role, I initiated, monitored and closed multiple Phase II – IV studies while interacting with and supporting investigators regarding study design, protocol development, CRFs, regulatory document maintenance, study drug tracking and other daily operational needs. I conducted regular site visited, reviewed and maintained files and ensured compliance and data quality in addition to preparing sites for FDA audits.► Performed above and beyond role requirements by writing abstracts for scientific meetings and writing the Integrated Summary of Safety (ISS) for an NDA.► Achieved all goals related to timeliness, accuracy and regulatory compliance.► Successfully aligned and established productive relationships with Key Opinion Leaders.

In this role, I supported multiple studies by revising informed consent, ordering supplies, completing CRFs and reviewing all grant related paperwork and payments for accuracy. I oversaw drug accountability, screened patients for inclusion, provided training for anesthesiologists and patients regarding protocols; administered study drug, assessed patient responses, collected adverse events and conducted required follow-up.