Stacy Foley

Experience

• 

  Turner - White Communications

  Jan 2000 - Jan 2003

  Acting Editor, Hospital Physician

  The magazine is dedicated to serving the changing needs of residents and practicing physicians in day-to-day clinical activities. The multispecialty, peer-reviewed journal informs residents about the broad range of fundamental clinical knowledge and skills required during hospital-based training. • Hospital Physicians journal supports the educational needs of its readers through the publication of clinical reviews, case reports, and articles describing emerging approaches to diagnosis and treatment• Initially hired as Assistant Editor, promoted to Associate Editor, and held the role of Acting Editor Show less

• 

  Merck

  Jan 2003 - Jan 2005

  Medical Program Documentation Specialist

  Initially hired as Regulatory Editing Associate, then promoted to Shared Services Lead, then Medical Program Documentation Specialist

• 

  Merck

  May 2005 - now

  Leading execution of a $100M suite of change initiatives and overseeing the global communications strategy across Merck’s GCTO organization.• Developed the GCTO PMO department from the ground up, currently overseeing a 20-member director-level team and rotational employees managing a multimillion-dollar project portfolio• Designed and initiated GCTO’s first Project Management COE (Center of Excellence), with a suite of standard project management tools, templates, and processes leveraged as best practices for PMOs across the company• Established a robust sponsor and stakeholder engagement matrix, enhancing project governance by improving senior leader visibility into and alliance across strategic initiatives • Redesigned Merck’s Clinical Trial Team (CTT) process, simplifying team structure, reducing meeting frequency to yield time savings and prioritize focus areas• Launched Site Focus, a quarterly publication creating an informal communication pathway with Merck’s site partners• Analyzed employee Pulse survey feedback and directed a multi-tiered action plan focused on addressing key concerns, including employee development and process simplification• Introduced significant changes to employee development, building substantial performance advancement opportunities, and overseeing the internship program for GCTO• Developed a set of functional competencies and associated learning library, culling previously scattered materials into one location, and establishing formal employee development resources to engage managers and promote continuous learning Show less Designed and guided RBM (Risk-Based Monitoring) implementation for Merck, coordinating and installing all aspects of the RBM paradigm with the onset of new ICH GCP principles on risk identification and mitigation.• Oversaw the RBM implementation Steering Committee, Core Team, and 7-cross functional work streams; designed and facilitated RBM orientation and training • Led vendor selection, onboarding activities, tech demos, sandbox, and user acceptance testing• Monitored RBM pilot trials and provided hypercare support to associated CTTs• Organized and hosted TransCelerate’s successful 2016 RBM Open House, which included 18 different partner companies and collaborating vendors • Speaker at RBM/quality oversight conferences, sharing Merck’s implementation approach; represented TransCelerate during a process overview presentation to Health Canada• As the Americas Regional Operations Support Lead, drove regional process design, management, and improvement activities Show less Championed quality improvements, developed new process management tools, and held relationship management responsibility for Merck’s investigative sites. Partnered with senior leaders and stakeholders within GCTO to evaluate processes and organizational structure and identify areas of need and opportunities to develop improved solutions.• Regularly developed and facilitated numerous team chartering and strategy development workshops for GCTO senior leaders • Created and issued Merck’s first site satisfaction survey, leveraging the associated net promoter score and feedback to launch efforts to improve site relations • Led the CRA Productivity Improvement Project, yielding a 10% FTC reduction, and contributing to divisional savings targets• Initiated a centralized process for collecting and tracking CRO time/resources, eliminating duplication, and improving visibility across organizations Show less Directed full-cycle clinical trial function, including strategic global business management and operational, financial, and technical leadership for the program across multiple therapeutic areas. Planned, executed, and monitored clinical studies, from recruitment plan preparation to patient enrollment, adhering to strict deadlines and budgets for optimal outcomes, and ensuring compliance with GCPs. Liaised with CTTs, subsidiaries, field monitors, and investigators for studies.• Oversaw premiere HIV drug ISENTRESS™ program through initial 2007 FDA approval, played a leading role in accelerating trial recruitment and study closeout activities• Served as Education & Training Lead, designed a new training program, recruited and oversaw SME personnel, and ensured proper measurement of key metrics to advance improvements • Served as CTT Subprocess Owner, authoring and maintaining CTT-related guidance documents, tools, and templates; managed the CTT Process Working Group Show less

  • Head, Global Clinical Trial Operations, Project Management Office (PMO)

    Dec 2016 - now

  • Global Risk-Based Monitoring Implementation Director

    Apr 2014 - Dec 2016

  • Quality Improvement & Process Lead

    Nov 2010 - Apr 2014

  • Senior Clinical Trial Manager

    May 2005 - Nov 2010