Study Management Associate III - Virtual/Multiple Theraputic Areas

Lake County, IL, US
Jul 27, 2018
Required Education
Bachelors Degree
Position Type
Full time
*Some positions are office-based.

Matrix management of functional areas and/or study vendors to ensure clinical study(ies) execution occurs per timelines. Individual is aware of both internal and external business environments and their impact on studies and escalates performance issues to management with possible solutions.

Key Responsibilities Include:
  • Supports clinical study execution and a position which will have minimal oversight and guidance.
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
  • Assist in the coordination of activities of a cross-functional team to ensure the initiation, conduct, and completion of one or more clinical studies are done on time and within budget. This may include assigned study region(s).
  • Lead study activities such as protocol preparation, investigator selection, site budget/contract development, investigator meeting, vendor selection, Case Report Form design, specification review and approval, and monitoring oversight.
  • Identify issues that potentially impact evaluable study data, ethical study conduct and International Conference on Harmonization {ICH) compliance and identify potential interventions or solutions to manage the issues.
  • Reports to a Study Project Manager with no direct reports but will begin to matrix manage a team.
  • May develop site study budgets with a manager's final approval and approve payments to sites and vendors after comparing invoice against an executed contract.

  • Bachelor's Degree or equivalent is required, typically in nursing or scientific field; Associate's Degree, R.N. or equivalent with relevant experience is acceptable.
  • Must have at least four years of Pharma-related/clinical research related experience and demonstrated a high level of core and technical competencies.
  • Possesses good communication skills.
  • Competent in application of standard business procedures {Standard operating procedures, International Conference on Harmonization {ICH), Global Regulations, Ethics and Compliance).
  • Preferred exposure to study initiation through study completion.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled