Patrecia Flynn-Valone's Email Addresses & Phone Numbers

📖 Summary

Global clinical research executive with experience in the pharmaceutical and CRO industries, including monitoring, project management, clinical operations management, outsourcing, quality control, and general management. Skills include in depth knowledge of clinical drug development processes, GCP/ICH regulations, and global business principles. • Demonstrated track record of building new organizations and accelerating growth while ensuring the highest quality standards and compliance with global regulations. • Recognized for a collaborative and open communication style that transcends local cultures and for persuading and empowering culturally diverse teams to embrace innovative business practices including Risk Based Monitoring, electronic Trial Master File (eTMF), and managing effective partnerships with Contract Research Organizations (CROs). • Successfully built and led high performing lean teams throughout Asia (Japan, Korea, Singapore, Australia, China, India, and South Korea). Served as a consultant to the Chinese Government on developing guidelines for inspecting clinical research organizations. • Possess a deep understanding of pharmaceutical market needs and strategic development of clinical trial design and execution in the Asia market to launch new medicines to meet the market needs. Specialties: Global clinical development operations, quality management in clinical trials, process improvement, cross-functional team leadership, project management, USA and Asia Pacific MarketsInterim Site Head, Senior Director Development Operations @ Member of the Global Development Operations and the Regional Development Center’s Senior Leadership team. Lead a lean flexible team of 25 employees in China, South Korea, Australia, and Singapore and provide strategic input into study programs and global initiatives on behalf of Asian region. Oversee contract research organizations, manage CRO partnerships in Asia, and other business partners to ensure timely delivery of all commitments, maximizing value-for-money and minimizing risk for Takeda. Currently managing 50 active clinical investigational studies Phase I through Phase IV with budgets ranging from $7 million to $25 million per study. Notable contributions: • Ensure that rigorous global standards and consistency are held for clinical investigational trials conducted in Asia. • Retained 100% of a high performing team with high morale during a large-scale company reorganization. • Collaborate across diverse teams and serve as a liaison to develop strategies for design, implementation, and testing new ways to conduct studies • Lead interaction with external stakeholders including regulatory authorities, thought leaders, and global therapeutic and product teams From June 2012 to Present (3 years 7 months) Director, Development Operations @ Recruited to build a lean and high performing development operations team in TGRD’s new office in Singapore. Responsible for the strategy, conduct and CRO oversight of the Global and Regional clinical investigational Phase I-IIIb studies in Asia. Accountable for large budgets and trial milestones. Served as a member of TGRD Asia Senior Leadership Team and global Clinical Operations leadership team. Provided strategic input into study programs and global initiatives on behalf of Asian region and championed the contributions of the Asian region within the global organization. From February 2011 to June 2012 (1 year 5 months) Sr Director Clinical Operations @ Promoted to turn around an underperforming region that faced distinct and specific challenges. Oversaw delivery of clinical trials in Singapore, Malaysia, and Taiwan. Led a lean team of 150 professionals throughout three countries. Managed a regional clinical development department, with responsibility for budgets, timelines, and compliance. Met with every employee to earn their buy-in, to identify issues and to empower people to make changes to the organization. From 2010 to 2011 (1 year) SingaporeDirector, Clinical Operations Quality Management Asia Pacific, China & India @ Member of the Asia Leadership Team. Oversaw quality management operations for clinical drug trials in 13 countries (SEA, Korea, India, Australia, New Zealand, China and Japan). Led a lean team of 22 regionally dispersed professionals and collaborated closely with the global quality management leadership team. Collaborated with the senior management team to develop a clinical operations quality strategy in Asia. Worked with global colleagues to provide regional clinical research insight while championing Asia’s contributions to the success of the global business. Planned, developed and led the implementation of operations project risk assessment at clinical research sites across the Asia. Interacted with clients, regulatory authorities, and presented to potential customers. Selected to serve on a cross-company team of pharmaceutical companies including Roche, Pfizer, Astra Zeneca, and Takeda to consult with the Chinese Government on developing guidelines for inspecting clinical research organizations (CRO). Wrote chapter in the Chinese government’s employee manual on how to inspect CROs. From 2009 to 2010 (1 year) SingaporeAssociate Director, Clinical Operations Quality Management, South East Asia (SEA) & Korea @ Developed a talent pool of 22 regional clinical operations quality management staff across the Asia region (SEA, Korea, India, Australia, New Zealand, China and Japan). Created and implemented regional operations quality plans by defining processes and communications. Oversaw a team that implemented CTMS and electronic Trial Master Files (eTMF) on clinical trials while ensuring that trials complied with regulations in the U.S., EMEA, and other countries. From 2008 to 2009 (1 year) SingaporeManager, Quality, Systems & Processes @ Selected to relocate to Asia to launch a global quality initiative and integrate it throughout Southeast Asia. Launched (multi-year project) 5 new global software systems (CTMS) and ensured that the employees, equipment, and tools were available in each country to successfully implement the program. Built a team to assess gaps in quality control processes for pharmaceutical clinical trials. Mentored junior operations team members on processes and systems. From 2007 to 2008 (1 year) SingaporeManager Clinical Operations @ Line management of clinical operations team across the Northeastern US (office and field based), responsible for resource allocation and flexible resourcing model for large pharmaceutical company. From 2005 to 2007 (2 years) Greater Boston AreaClinical Trial Lead / Senior Clinical Research Associate @ From 2002 to 2005 (3 years) Greater Boston AreaMS, Nutrition @ University of Masssachusetts - Amherst Patrecia Flynn-Valone is skilled in: CTMS, CRO, Clinical Development, Clinical Research, GCP, Pharmaceutical Industry, Clinical Trials, Clinical Operations, Drug Development, ICH-GCP, EDC, Clinical Monitoring, Oncology, Therapeutic Areas, Cross-functional Team Leadership, Pharmaceutics, Pharmacovigilance, Regulatory Submissions