Sheryl Fields Email & Phone Number

Columbus, Indiana

• Provide operational management of multicenter clinical trials from start up to close out through close collaboration with both the client, vendors and all involved company functional group team members.
• Participate in development of all applicable study documents and plans.
• Ensure creation of master timelines for all trial activities. Monitor timeline activities and immediately notify all appropriate team members (company and client) towards contingency planning and resolution of issues.
• Establish roles and responsibilities with all team members/functional groups and continually assess group activities and quality of work.
• Ensure client is immediately made aware of any issues which may impact milestones or quality and provide specific plans for resolution.
• Ensure all client directives and significant discussions outside of meeting minutes are documented and filed to Trial Master File as required.

• Responsible for the overall coordination and management of clinical trials from protocol design through clinical study report.
• Directed operational aspects of the project (including over-sight of CROs and Vendors) to ensure compliance with FDA regulations and company SOPs.
• Worked across functional areas (including Clinical Packaging, Data Management, Biostatistics, Monitoring, Safety and Medical Writing) to identify and evaluate issues, and implemented solutions in order to ensure.
• Provided input to Data Management regarding CRF design and implementation of EDC and Electronic Diary systems including initial user acceptance testing of utilized systems.
• Oversaw project specific training for project and functional team members.
• Formulated budgets, analyzed costs, and project needs to determine the most cost effective and efficient means to ensure that all project deliverables were met within budget constraints

• Responsible for management of all aspects of clinical site participation in trials from initial site identification through collection of final study documentation and archiving at study closure.
• Oversaw all site interaction including, clarification of study procedures, protocol adherence and monitoring issues.
• Managed clinical supplies including study drug distribution.
• Negotiated contracts and study budgets and managed site payments. Initial set up and ongoing maintenance of study and site regulatory files.

• Performed in-house review and query issue for clinical data both in hard copy and electronic form (EDC).
• Performed audits of SAE Reports, med watches, clinical study reports and other related study documents.

• Responsible for management of all aspects of clinical trial implementation including regulatory documents, data collection and direct subject interaction.
• Provided CRF and informed consent development, creation of instructional manuals and source document worksheets for national investigator initiated, sponsor funded trials.
• Served as regional and national resource coordinator for multi-center trials including management of participating site regulatory documents, interaction with sites, and document collection.
• Served as faculty contributor and authorized presenter for Projects in Knowledge, Inc. Program: “Care & Counseling; Helping Patients Stay The Course on Treatment for Hepatitis C” (Schering-Plough funded)