Experience

Cidara Therapeutics
• United States
• Biotechnology
• 1 - 100 Employee
• Associate Director, Clinical Operations

  • Aug 2021 - Present


Pfizer

• Events Services
• 1 - 100 Employee

• Associate Director, Global Lead Study Manager

  • Jul 2014 - Aug 2021

  Responsible for leading cross-functional operational teams, including oversight of contracted Clinical Research Organization and various vendors, to ensure the timely delivery of high-quality trials conducted in healthy volunteers and patients at multiple large institutions and private practices in up to 14 countriesDUTIES AND RESPONSIBILITIES• Responsible for the planning and delivery of a defined clinical project to scope, quality, budget, time, managing resource and risk.• Responsible for project management including the development and maintenance of realistic, up to date and appropriate quality, project and study plans• Contribute to and support selection of all study-related vendors (RFP, Bid Defense, Contracting).• Provide input into study feasibility, study specifications, vendor/partner contracts and essential documents such as clinical study protocols, informed consents, CRFs, CSRs, etc.• Manage a clinical study and the associated processes to identify and solve operational issues and drive delivery to plan through internal or external partners.• Act as operational interface with external contract/vendor partners (e.g., CROs, Central Labs). • Ensure successful delivery of all study lifecycle deliverables (RFP through completion of the Trial Master File).• Review and approve contracts, work orders and invoices for execution or payment.• Establish and maintain effective communication and collaboration with functional area peers, in order to meet program objectives and support achievement of goals. Show less

• Clinical Research Operations Manager

  • Jul 2014 - Jun 2021



BioBridges, LLC

• United States
• IT Services and IT Consulting
• 1 - 100 Employee

• Clinical Project Manager

  • Aug 2013 - Nov 2013

  Disease Area: Pain (postherpetic neuralgia [PHN] / lumbosacral radiculopathy [LSR]) Oversee the operations and activities of 3 contracted Clinical Research Organizations (CROs) and 8 other external vendors in the conduct/close-out of Zalicus clinical trial projects. Collaborate with internal team members to drive the timelines for 2 Phase II domestic clinical trials, execute compliance and quality initiatives, and achieve deliverables while alleviating risk. * Collaborate on and ensure adherence to study operational plans, protocols, and informed consent forms * Coordinate internal and external clinical development activities of all team members involved in the conduct and close-out of assigned clinical trials * Ensure delivery of and oversee daily and weekly study enrollment tracking/metrics reporting * Analyze protocol deviations and establish criteria/determination for per protocol evaluability * Contribute to data listings/tables review and facilitate other database lock/clinical study report activities * Draft and implement clinical standard operating procedures (SOPs) * Facilitate document review and approval/document filing to clinical study portal * Attend CRO and vendor meetings and review minutes and ensure timely resolution to action items. Show less



Amarin Pharma Inc

• Clinical Study Manager

  • 2010 - Aug 2013

  Associate Clinical Study Manager, in collaboration with the Clinical Development team, responsible for the day-to-day operations for multiple clinical studies from protocol feasibility through protocol development & project planning, study implementation, conduct, close-out and final clinical study report. Achieve this purpose by coordinating and overseeing the activities and deliverables of all study conduct partners (internal departments, contract research organizations [CROs], vendors, site monitors, consultants, etc.) to meet the primary deliverable that is high-quality, timely and cost-effective data. Proactively identify and manage issues. 5-Phase I studies, 2-Phase 3b studies (12 countries), 1-Outcomes study (9 countries)  Participated in study vendor selection (review of Requests for Proposals [RFPs], participation in Bid Defense Meetings)  Reviewed and implemented Master Service Agreements/Task Orders with CROs, vendors  Reviewed and approved CRO processes specific to the studies (communication plan, monitoring plan, data management plan, regulatory document submission plan, IVRS specifications, safety plan)  CRO invoice approval and study budget tracking  Participated with Regulatory team to conduct CRO/Site Audit  Assisted with review and preparation of NDA Submission with progression through to FDA Approval and achievement of Commercial Launch of product  Understanding of the clinical development process and knowledge of operational clinical trial methodology knowledge and understanding of good clinical practices (GCP/ICH) and regulatory requirements. Show less



ExecuPharm, Inc

• United States
• Human Resources Services
• 1 - 100 Employee

• Clinical Trials Associate

  • 2005 - 2010

  Disease Areas: Obesity (obese and diabetic obese subjects), Hepatitis C virus (HCV), Invasive candidiasis, candidemia, and esophageal candidiasis in Pediatrics, Alzheimer’s disease  Partner with US and international Study Managers and teams on 4 multi-international Phase 2 and 3b trials successfully progressing the studies from study start-up through continued maintenance, and two of the four studies to final close-out  Sole project support for 7 Study Managers covering 280 sites (over 3000 subjects) within 19 countries (US and international) during study start-up, conduct, and close-out of Phase 3 program (4 protocols). Served as sole study management point of contact for finalizing and approving site payments to investigators after early termination of entire program  Competent and well-versed regarding protocol feasibility, pre-trial assessment, site selection, production of overall protocol documents, site guidance documents as well as subject-directed materials, site start-up tracking, logistics and execution of Investigators Meetings and Monitor training, shipment coordination of supplies to countries/sites  Generated and distributed individual site invoice templates for US investigators extracting finance criteria from the multi-million dollar clinical trials budget, and investigators’ site budgets and contracts  Archived essential documents within Trial Master Files and team-specific document storage systems  Manipulated and updated web-based investigator site trials portal with study team newsletters, enrollment data, protocol and site guidance documents, alert notifications  Presented to large groups on various topics including: Investigator Meetings (domestic and international), lessons learned from taking a program from study concept direct through to final close-out, and Creative Services  Served as mentor to colleagues and served on an initiative team developing global Clinical Trials Associate task list Show less