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Successful 28+ year track record of managing teams and research programs for top academic institutions as well as a top 3 CROs and Fortune 300 pharmaceutical companies. Proven track record of meeting study timelines on global trials effectively and within budget as well as retaining internal and external staff.Specialties: Global program management, vendor management, oncology, neuroscience, psychiatry, urology, psychology, vaccines, respiratory diseases, oncology, Latin America, South America, APAC, Eastern Europe, Phase 1-4, IT solutions, Veeva Vault, Sharepoint, Documentum software programs. Other areas include: post marketing studies, expanded access expertise, cardiology, erectile dysfunction, medical devices, urodynamics, addictions, PK and PD studies Successfull execution of global clinical trials in Biotech, Pharma, and CROs Effectively managed multiple large scale, global projects concurrently meeting timelines and deliverables Supported company focused enhancement projects Provided strategic input for compound portfolio development Supported and provided input with technological solutions such as building collaborative web solutions, wearables, eTMF system builds, and telehealth solutions Diverse therapeutic exposures as well as age ranges (premature infants to geriatrics) Responsible for building, forecasting and managing budgets Provided vendor oversight Managed direct reports and cross functional teams globallyExtensive experience with audits, inspections, and submissions Bilingual – English and German
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DirectorThor CompaniesHenderson, Nv, Us -
Associate Director, Clinical OperationsTaiho Oncology, Inc. (Formerly Astex Pharmaceuticals) Jan 2024 - Apr 2024Formerly Astex PharmaceuticalsProvided operational oversight of multiple oncology programs and studies Provided strategic input for multiple oncology programs Responsible for global timelines and budgets Lead and provide oversight of global cross functional study teams Lead and provide oversight of CROs and additional vendors Provide oversight and contribute to the development of protocols and other program documents Managed up to four direct reports Ensured resources are managed sufficiently across portfolios Developed new eTMF system for company in partnership with Ostuka and Taiho Developed and assess SOPs and alignment with global partners within Otsuka Holdings Responsible for oversight of LOINC collection and vendor for company wide effort Integral member of alliance partnership with additional Otsuka companies across a portfolio
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Associate Director Clinical OperationsAstex Pharmaceuticals, Inc. (Us) Sep 2021 - Jan 2024Pleasanton, Ca, UsProvided operational oversight of multiple oncology programs and studies Provided strategic input for multiple oncology programs Responsible for global timelines and budgets Lead and provide oversight of global cross functional study teams Lead and provide oversight of CROs and additional vendors Provide oversight and contribute to the development of protocols and other program documents Managed up to four direct reports Ensured resources are managed sufficiently across portfolios Developed new eTMF system for company in partnership with Ostuka and Taiho Developed and assess SOPs and alignment with global partners within Otsuka Holdings Responsible for oversight of LOINC collection and vendor for company wide effort Integral member of alliance partnership with additional Otsuka companies across a portfolio -
Sr. Project ManagerSeattle Genetics On Behalf Of Execupharm Aug 2020 - Sep 2021Bothell, Washington, UsFunctional service provider through Execupharm serving Seattle Genetics.Provided Project Management oversight of oncology projects Responsible for global timelines and budgets Managed global cross functional study teams Provided oversight of CROs Provided vendor management and oversight Partnered with additional sponsor company to transition projects within partnerships and assist alliance partnership Conducted programs across multiple Sponsors -
Consultant, Supporting Takeda PharmaceuticalsThe Evanston Group, Inc. Mar 2020 - Aug 2020Chicago, Illinois, UsProviding support and oversight within the global Oncology Therapeutic Area for Takeda Pharmaceuticals Management of projects on a global scale with focus on start-up, timelines, budget, vendor management, and teams management. -
Sr. Project ManagerPpd May 2014 - Mar 2020Wilmington, Nc, UsEffectively managed projects across portfolios as well as global teams Created strategic strategic and operational plans tailored to the particular needs of all phases of studies in development phase studies globally. Lead cross-functional teams Multiple therapeutic areas included Provided expertise and guidance with global trial needs to Clients and staff Subject matter expert for non interventional projects and programs Supported technological solutions for trials including wearables and telehealth Primarily responsible and accountable for accomplishing contractual project deliverables Participated in bid defense meetings as appropriate Assisted the Business Development group with revising their overall strategy and materials for bid defenses and proposals Worked closed with the newly developed office in Japan to provide both Business Development and Clinical Operations support to build their office capabilities Provided subject-matter expert input into late phase proposals Oversaw financial management of projects Provided vendor oversight Provided support and expertise to teams for country level specifics -
Clinical Program ManagerGilead Sciences Sep 2012 - Apr 2014Foster City, Ca, UsClinical Program Manager in Oncology TA• Optimized drug development by providing expert scientific input Coordinated the planning and execution of multiple global Phase 3 Oncology trials Directed resources, projects, ongoing trials and new trial start-ups Managed study budgets and project timelines for global trials Selected and managed multiple vendors Ensured studies were conducted within regulatory requirements, timeframes and budgets Developed clinical protocols and study materials Managed approximately five clinical operations team members -
Sr. Clinical Project ManagerCell Therapeutics, Inc. Nov 2011 - Sep 2012Seattle, Wa, Us• Optimized drug development by providing expert scientific input Coordinated the planning and execution of multiple global Phase 3 Oncology trials Directed resources, projects, ongoing trials and new trial start-ups Managed study budgets and project timelines for global trials Selected and managed multiple vendors at the study and corporate levels Ensured studies are conducted within regulatory requirements, timeframes and budgets Developed clinical protocols and study materials Provided strategic program level oversight Managed clinical operations team members -
Clinical Program ManagerMedimmune May 2010 - Nov 2011Gaithersburg, Maryland, Us• Coordinated the planning and execution of post-marketing studies, phase 1, phase 2 and post-marketing studies Directed resources, projects, ongoing trials and new trial start-ups Managed study budgets and project timelines for global trials Selected and managed multiple vendors at the study and corporate levels Developed clinical protocols and study materials Managed approximately three clinical operations team members Oversaw CRO activities • Core team member for eTMF development and implementation representing Clinical Operations and Medical Affairs.• Managed multiple individual study budgets and vendor budgets up to 3 million/year. -
Clinical Study ManagerAllergan Oct 2007 - Dec 2009Dublin, Coolock, IeDeveloped and coordinated the planning and management of Phase 3 global Urology studies including timelines, budgets, vendors, internal and external teams, multiple CROs in multiple regions Managed teams to oversee sites, study initiation, execution, monitoring and completion Assisted in developing monitoring plans, ICFs, study manuals, pharmacy manuals, training materials, video scripts, and design CRFs Managed in-house CRAs, contract CRAs, and administrative personnel Managed study budget and project timelines Developed regulatory responses and ethics committee responses for Latin America Migration Oversight Committee member for Project Phoenix for development and migration activities related to the electronic document management system Provided consultation from the Clinical Department for development and integration of multiple electronic systems across the company Provided vendor oversight -
Principal Clinical Research AssociateAllergan Apr 2007 - Sep 2007Dublin, Coolock, IeManaged all aspects of global clinical trials Developed and coordinated the planning and execution of global Phase 3 studies Managed activities around study sites, study initiation, execution, monitoring and completion Interfaced with key individuals in Regulatory Affairs, Project Management, Research Compliance, Marketing, and Data Management/Biostatistics Assisted in developing monitoring plans, ICFs, study manuals, pharmacy manuals, training materials, and video scripts, and design CRFs Managed study budget and project timelines Developed regulatory responses and ethics committee responses for Latin America -
Clinical Development AssociateEli Lilly Oct 2000 - Jan 2007Indianapolis, Indiana, Us• Managed all aspects of spontaneous regulatory requests for data Managed all aspects of completion of regulatory compliance documents for neuroscience compounds Participated as core team member in activities involved in improving and standardizing the overarching external research process from a global perspective utilizing Six Sigma methodology. Co-led team to develop global training, SOPs, and global communications at all levels Managed External Research Programs for the Neuroscience Platform compounds as the Gatekeeper for Zyprexa, Symbyax, and Strattera prior to becoming the Gatekeeper for Cymbalta and Yentreve. Oversee all aspects of the external research programs for all Neuroscience compounds and Yentreve including but not limited to initial review, Committee review and decision-making processes, and budget Reviewed and managed individual study budgets as well as manage the overall budgets related to external research for the neuroscience Global Brand Development Teams and Platform Teams Managed forecasted and actual amounts as well as decisions related to new commitments. Budgets ranged from 1.2 million per compound to 3.2 million per compound Managed Lilly sponsored clinical trials within the Neuroscience division as an in-house clinical development associate Managed Phase 3 studies in Neuroscience with responsibilities that included but were not limited to managing study communications, ensuring site and monitor compliance with the protocol and FDA/GCP/ICH regulations, managing study drug shipments, managing serious adverse event reporting, increasing enrollment rates, facilitating milestone payments, etc.
Shelley Evans Skills
Shelley Evans Education Details
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West Virginia UniversityPsychology
Frequently Asked Questions about Shelley Evans
What company does Shelley Evans work for?
Shelley Evans works for Thor Companies
What is Shelley Evans's role at the current company?
Shelley Evans's current role is Director.
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What is Shelley Evans's direct phone number?
Shelley Evans's direct phone number is +130162*****
What schools did Shelley Evans attend?
Shelley Evans attended West Virginia University.
What are some of Shelley Evans's interests?
Shelley Evans has interest in Exercise, Sweepstakes, Home Improvement, Reading, Gourmet Cooking, Sports, Christian Worship Singer, Golf, Home Decoration, Health.
What skills is Shelley Evans known for?
Shelley Evans has skills like Oncology, Vaccines, Cardiology, Neuroscience, Medical Devices, Neurology, Psychiatry, Quality Assurance, Urology, Project Planning, Neuropharmacology, Psychology.
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