Troy Balkum

Experience

1. Clinical Project Lead, Usa

   ICON plc

   Mar 2020 — Present · Raleigh, NC, US

   Performed as USA lead on Ophthalmology Studies (SAR422459 and SAR421869)\\\\n\\\\n· Performed as USA lead on MS Studies (OBS14527 and OBS13434)\\\\n\\\\n· Performed LSF Audits for all Studies within the Bridgewater NJ Campus\\\\n\\\\n§ Ensure study team members (local and global) are informed of study expectations, plans and status\\\\n\\\\n· Oversee assigned studies, ensuring completion on schedule and within budget.\\\\n\\\\n· Ensure that all assigned clinical studies are conducted according to Good Clinical Practice, ICH, Standard Operating Procedures, local laws, and Policies and Procedures.\\\\n\\\\n· Organize study specific training and regular team meetings for the local project team, study staff and all CSU functions as needed.\\\\n\\\\n· Collaborate closely with monitoring vendor and CRA managers to ensure study timelines, commitments, quality and expectations are known and met\\\\n\\\\n· Ensure study files, payments and study data completion are up to date and thorough.\\\\n\\\\n· Maintain regular contact with Medical Advisors, Medical Affairs, Monitoring team, global teams and all local CSU functions in order to always be up to date on strategies and changes in the environment.\\\\n\\\\n· Negotiate and liaise in a professional manner with customers regarding all aspects of the project.\\\\n\\\\n· Manage administrative files (budget, monitoring report)\\\\n\\\\nTake part in developing objectives and action plans for reviewing and improving work processes.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n