Joseph Sheppard

About Joseph Sheppard

Experienced Clinical Project Lead with a demonstrated history of working in the pharmaceuticals industry. Skilled in Healthcare, U.S. Food and Drug Administration (FDA), CRO Management, Nursing, and Clinical Trial Management System (CTMS). Strong healthcare services professional with a MBA focused in Business from University of North Carolina at Wilmington.

Experience

1. Senior Clinical Trial Manager

   ICON plc

   Feb 2021 — Present · Wilmington, NC, US

   Specific duties include:• Produce, implement, analyze, and follow recruitment plans and key milestones for assigned studies• Oversee assigned studies, ensuring completion on schedule and within budget.• Ensure that all clinical studies are conducted according to Good Clinical Practice, ICH, Standard Operating Procedures, local laws, and Policies and Procedures.• Anticipate project requirements and institute appropriate actions to ensure timelines, quality standards, country commitments and budget are met.• Organize study specific training and regular team meetings for the local project team, study staff and all client CSU functions as needed.• Collaborate closely with monitoring vendor and other designees to ensure study timelines, commitments, quality, and expectations are known and met• Organize and participate in investigators or study meetings as needed.• Establish, track, and maintain study specific trial management tools/systems.• Ensure study files, payments and study data completion are up to date and thorough• Maintain regular contact with Medical Advisors, Medical Affairs, Monitoring team, global teams, and all local client CSU functions to always be up to date on strategies and changes in the environment.• Negotiate and liaise in a professional manner with customers regarding all aspects of the project.• Negotiate contracts and sign contract agreement forms and grant agreements for assigned studies• Produce study budget estimates and ensure timely payments and budget tracking• Provide local and Global Management with data on such matters as recruitment of subjects and other performance measures compared to the estimated plan.• Manage administrative files (budget, monitoring report).• Travel as necessary, consistent with project needs and management needs.• Develop action plans for reviewing and improving work processes• Study phases managed include Study start-up, Monitoring, Study Closeout Experience with audits and inspections

Education

• University of North Carolina Wilmington

  MBA, Business

• University of North Carolina Wilmington

  Bachelor of Arts - BA, History

• University of North Carolina Wilmington

  BSN, Nursing

Skills

• Clinical Trials
• Ms Office Suite
• Ich-Gcp
• Pharmaceutical Industry
• Site Management
• Registered Nurse
• Solid Tumors
• CRO
• Chronic Lymphocytic Leukemia
• Oncology
• Protocol
• Clinical Monitoring
• Clinical Trial Management System (Ctms)
• Gcp
• Impact
• U.s. Food and Drug Administration (Fda)
• Healthcare
• Clinical Cardiology
• Smart Report Software
• Regulatory Submissions
• Clinical Development
• CRO Management
• Diabetes
• Endpoint Irt
• Rave Edc
• Data Management
• Clinical Research
• Standard Operating Procedure (Sop)
• Good Clinical Practice (Gcp)
• Regulatory Affairs
• Electronic Data Capture (Edc)
• Acute Myelgenous Leukemia
• Interventional Cardiology
• Edc
• Therapeutic Areas
• Cardiology