Clinical Operations expert with extensive experience in clinical drug development, resulting in successful delivery of multinational pivotal clinical trials within time, cost and quality targets across a range of indications and therapeutic areas. Strong knowledge of ICH/GCP guidelines and processes associated with clinical trial operations from IND to sNDA and sBLA submission and defense, having participated in submissions in the US, EU and Japan. Demonstrated excellence in Project Management including building and leading cross-functional and multinational teams, planning and delivering projects to plan, risk identification and mitigation. Skilled in building successful relationships with external and internal stakeholders throughout all levels of a matrix organization, managing complex organizational change, problem solving, and teaching and mentoring, with a strong commitment to process improvement. Experience includes 10 years as a Clinical Research Associate (CRA) with site management and monitoring responsibilities for Phase I-IV clinical trials.
Experienced Associate Director/Senior Clinical Project Manager well versed in all aspects of clinical trials from writing protocol to CSR submissions; extensive industry experience in developing protocols, conducting IMs, monitoring studies from site initiation to close-out, creating study plans, and site and vendor management; thorough understanding of product development from pre-clinical through NDA submissions; expertise in drug development, strategic planning, project management, planning, risk assessment, and budget/finance management including study projections.
Driven executive with more than 20 years of excellence in biopharma and CRO leadership across therapeutic, device and technology based companies. Extensive operational skills in privately funded, early-stage companies. Established history of problem solving, creative execution and high quality business performance.
Recognized ability to lead the development and implementation of clinical programs, from initial protocol development through clinical trial execution, CSR completion and NDA filing. Translates requirements into specifications for systems and integrates knowledge with research. Project leadership and clinical trial design and implementation across a global program. Knowledgeable of both US and international regulatory requirements and well versed in applicable CFR, ICH/GCP and European guidelines. Excellent supervisory, communication, and team leadership skills. Exceptional customer service and client relations. Highly organized, detail oriented and thorough, with the proven ability to deliver program results on time and within budget.
More than 25 years of increasing responsibility in the clinical research industry, including: Sr. Director of Clinical Operations at a startup biotech; built a clinical operations department from the ground up; client services / management at a CRO; clinical program / therapeutic area portfolio director at a CRO; extensive clinical study management (including international); functional line management; both pharmaceutical / biotech and CRO experience; extensive experience developing and managing clinical budgets; vendor identification, selection, contracting and management; SOP development; team and program resource allocation; Phase I through Phase 4 clinical trials; excellent written and oral communication skills; excellent team leadership skills; proven ability to meet or exceed team timelines in a matrix environment; excellent client and vendor relationships (resulting in dedicated vendor partners and significant awards of additional client business while at CRO).
Medical industry development (clinical and academia training provider; endorsed by RNZCGP to provide GCP training as part of GPs continuous medical education (CME); regular trainer for Auckland University and the National Institute of Health Innovation); Broad therapeutic knowledge (International R&D experience in Australasia (SE Asia), North American and Europe of Pharmaceutical, CRO, Site Management Organizations and Biotechnology); Strong management skills (extensive experience of clinical operations, project management and line management); Business development (awareness of market forces, developing strategic new relationships); In depth knowledge of both primary and secondary health sectors (internationally); Presenting (seminars, workshops, arranging and hosting medical industry events).
Accomplished clinical research / medical affairs professional with demonstrated success in a multitude of roles across numerous therapeutic areas and study phases; out-of-the-box strategic thinking, hit-the-ground running type of individual who functions autonomously at a high level and thrives in unique and challenging environments; provider of high quality independent consulting services to Biotechnology and Pharmaceutical clients in support of site identification, study start-up activities, patient recruitment/retention, and the ongoing conduct of clinical trials.
Hands-on leadership experience in the clinical trials industry including clinical trial monitoring, site management, GCP auditing, regulatory, and clinical research operations; experienced leader of cross-disciplinary global and virtual project/protocol teams; ability to implement and coordinate both strategic and tactical plans to enhance program/personnel performance; in-depth knowledge of the clinical trials process including study design, regulatory requirements, ICH/GCP guidelines, and compliance; skilled in problem solving and affecting positive change through project management, training, or other methods; highly organized with an attention to detail and ability to maximize resources to achieve increased productivity, meet deadlines, and facilitate organizational goals; persuasive, with ability to communicate effectively with diverse audiences - public speaking and executive management briefing experience.
Clinical Research Professional with 16 years' industry experience in Clinical Operations and CRO/Vendor Management. Therapeutic experience includes: Cardiovascular, Dermatology, Oncology, GI, Diabetes, Vaccines, Surgical implant and Medical Devices Phases I-IV.
Consultant, Clinical Operations with extensive experience and success managing clinical programs and studies in all phases, who adapts to diverse environments and leadership cultures. Effective at course-correcting and overseeing challenging clinical trials by maximizing resources, and increasing collaboration among people of all levels. Demonstrated ability to manage CROs and vendors (domestic and international) due to excellent communication and relationship-building skills, as well as a self-directed and high-stamina nature.
Pharmaceutical, biotech, medical device, manufacturing and research and development professional with 17+ years of experience at companies of all sizes; experienced and effective managing and navigating cross-functional and global environments as well as all phases of regulatory, R&D, and product development lifecycles; experience in Phase I through IV clinical trials management; vast experience selecting and managing CROs with RFPs, contracting, auditing and ongoing oversight; skilled in negotiating CRO and other vendor contracts/budgets; skilled at developing and motivating teams; ability to lead and manage multiple teams/projects/tasks simultaneously; strong ability to adjust to changing project demands and objectives; excellent interpersonal and organizational skills; great attention to detail; strong verbal and written communication skills. Global trial experience in North America, Latin America, Europe, Asia, and India. Therapeutic experience: Autoimmune, Cardiovascular, CNS, Dermatology, Diagnostic Device, Endocrinology, Gastrointestinal, Hematology, Internal Medicine, Immunology, Infectious Disease, Neurology, Oncology, Ophthalmology, Pulmonary and Urology.