Glenview, Illinois, United States
Experienced Associate Director with a demonstrated history of working in the pharmaceuticals industry. Strong consulting professional skilled in Electronic Data Capture (EDC), Oncology, Clinical Data Management, Good Clinical Practice (GCP), and Clinical Research.
· Provides tactical and strategic clinical operations oversight and direction ensuring collaboration across a project(s)/program to translate science into reality through high quality clinical trial conduct. · Ensures studies within a project(s)/program are conducted on-time, within budget and with quality · Develop and execute project/program-specific project and risk management plans ensure appropriate escalation as needed · Oversee the strategic selection of project/program-wide vendors and ensure consistency and compliance across all studies within a project/program · Develop and assess cost and resource projections of project/program for portfolio plan · Integral participant at advisories, interactions with regulatory agencies and evaluation of business opportunities · Represent Clinical Program Development on strategic governance bodies
Responsible for compliance with applicable Corporate and Divisional Policies and procedures. · Leader of multiple study teams · Development of the Study Plan which includes key milestones, timelines cost and resources, Monitoring, Communication, IP, Recruitment & Retention Plans. · Provide input to clinical regulatory documents (e.g., Investigator’s Brochure (IB), CSR, CSS, CSE, CO, and the IND Update). · Author Protocol and related study documents with input from Therapeutic Area, and other key stakeholders. · Contribute to country selection at study level and drive site selection · Oversee and/or manage vendors (e.g., CROs, laboratories, etc.). May identify and select vendors, as appropriate · Assess and provide study status updates/progress reports to ensure key elements are clearly communicated to the appropriate cross-functional team members · Contribute to the development of and testing of the specifications of systems (e.g., EDC, IRT, ePRO, etc.) · Ensure all systems (e.g. CTMS, CT.gov,) reflect current study status. · Plan and coordinate internal and external meetings (e.g., Investigator Meetings and monitor meetings) · Responsible for content development and delivery of internal and external study-related training · Ensure effective study communications to internal and external stakeholders through meetings, presentations and other methods. (i.e., cross-functional teams) · Communicates regularly with extended study team including Regional Managers to review country/site status, issues, study timelines and ongoing data quality. • Ensure development, quality consistency and compliance of clinical study (s) • Evaluate study-level issues and execute action plan to ensure resolution. • Actively identifies and address quality and compliance concerns. • Ensures audit / inspection readiness at site level. Prepares audit/ inspection responses as part of cross-functional clinical study team.
Manage the daily operational activities associated with the conduct of clinical studies monitored by Abbott in accordance with country-specific regulations, Good Clinical Practices (GCPs), ICH Guidelines, Abbott Standard Operating Procedures (SOPs), and business processes. Serve as a contact for clinical site personnel and Abbott Regional CRAs for study-related questions. Direct the activities of regionally based CRAs as they relate to the monitoring of assigned studies. Function as a day-to-day resource for Regional CRAs for protocol-related questions. Collaborate with other internal functional groups to manage study issues and support milestone achievements. Interact with and build professional and collaborative relationships with all study personnel (investigators, study coordinators, pharmacists, etc), peers and office-based personnel. Uses multiple technologies to maintain open and frequent communication with Abbott personnel Work with Clinical Program Management (CPM) team members to assure adherence to intended timelines, including enrollment, delivery of clinical supplies, and data delivery. Experience managing multi-therapeutic areas including Anti-Viral (Hepatitis C), Acute Pain, Rheumatoid Arthritis, Oncology, and Neuroscience.
I audit clinical trials and ensure doctors participating on a given clinical trial are appropriately testing the drug on their subjects and following FDA regulations. I have worked in the following therapeutic indications: Renal Transplant, Psoriasis, Rheumatoid Arthritis, Melanoma, GIST, Pancreatic Cancer, NSCLC, Breast Cancer, Hepatocellular, Alzheimers, Allergy and Infections (Aspergillosis and Hepatitis C).
I worked in the Infectious Disease laboratory within the Boston Medical Center while a graduate student at Boston University. We analyzed genomes of species closely related to Francisella tularensis to create a diagnostic tool.