Director, Integrated Clinical Programs @ From May 2012 to Present (3 years 8 months) Director, Clinical Operations @ Study Leader of multinational Diabetic Foot Ulcer trial of 25 sites with Integra® Dermal Regeneration Template. Directed operational activities of ~19 company supported Investigator Initiated Studies. Clinical contributor & reviewer of Health Hazard Assessments, Risk Management Plans, Failure Mode
Director, Integrated Clinical Programs @ From May 2012 to Present (3 years 8 months) Director, Clinical Operations @ Study Leader of multinational Diabetic Foot Ulcer trial of 25 sites with Integra® Dermal Regeneration Template. Directed operational activities of ~19 company supported Investigator Initiated Studies. Clinical contributor & reviewer of Health Hazard Assessments, Risk Management Plans, Failure Mode Effect Analysis for inclusion in collagen products' design history files. Chaired Cross-Divisional Director level-forum to review SOPs, improve work flow, and share best practices. From August 2010 to October 2011 (1 year 3 months) Clinical Study Manager, cardiovascular @ Developed Global study implementation plans and managed operational aspects of the ENGAGE AF – TIMI 48 study in North American (NA) Region. Influenced interactions with CRO (Quintiles), ARO (TIMI), and non-clinical functions of Daiichi Sankyo (DS) to meet company timelines for FDA approval of DU-176b. Authorized multi-million dollar CRO and other vendors’ invoice payments. Developed DS Monitoring Report Review process. From February 2009 to July 2010 (1 year 6 months) Sr. Territory Manager of CRAs @ Executed research strategy within assigned territory (PA, NY, & Eastern Ohio) through evaluation of CRA recommendations of investigators and management of CRA workloads. Actively monitored project status to ensure timely reporting of adverse experiences, promoting data quality, and efficient site management practices in compliance with ICH-GCP Guidelines and internal Clinical Research Operations-US (CROps US) policies.
·Mentored CRAs to maintain positive relationships with Scientific Leaders and High Performing Investigators to promote faster study initiations.
·Trained and coached CRAs through major change management period (business process and technical system implementation) achieving expected efficiencies.
·Chosen as the only Domestic CROps representative to meet with the FDA Inspector for 2 New Drug Application Sponsor Audits to answer questions about US Site Monitoring procedures.
·Selected by CROps Executive Director as US Lead on International Team to standardize Site Monitoring Procedures worldwide. Key contributor in writing and reviewing these documents. Presented the new procedures to over 200 US CRAs and contributed to FAQ Reference Guide.
·Revamped Manager’s Trip Report Template and associated procedure to be aligned with new metric-driven focus leading to new process adoption more fully. From 1983 to July 2008 (25 years) Promotions Manager- Worldwide @ From 1994 to 1997 (3 years) Project Manager/ Project Planning @ From 1989 to 1994 (5 years)
Masters Public Administration, Health Care @ California State University-Long BeachBS, Nursing @ Rhode Island College Judy Matarese is skilled in: managing international teams, Study Team Leader - oversee CRO & clinical trials, thorough knowledge of drug development & clinical trial management, effective communicator with internal & external partners, oversee or perform feasibility assessment & investigator/ site selection, managing projects, Managing Employees, development, evaluation, & improvement of processes and procedures, generator of new ideas, knowledge & compliance with ICH-GCP, FDA 21 CFR
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