Associate Director, Clinical Operations

Responsible for maintaining and managing a highly skilled, stable and functional in house monitoring team to meet the developing needs of the Global Oncology business and developing and rolling out new monitoring processes and work instructions to best implement consistency and efficiencies.

Responsibilities

  • Collaborate closely with Study Leads utilizing regional clinical monitors to ensure study monitoring needs are being met and monitoring activities are being performed according to expectations and the monitoring plan.
  • Oversee site assignments to work to ensure best “fit” with known sites and study teams.
  • Assist with finding coverage for adhoc monitoring needs for specific studies.
  • Provide direct line management of regional clinical monitors.
  • Arrange for orientation, onboarding and general Global Oncology business required training activities.
  • Assess regional clinical monitor performance via co-monitoring activities, report review, 1:1s, site and study lead/team feedback.
  • Institute consistent process, trackers and work instructions as relates to regional clinical monitoring activities for the Global Oncology business including SOPs, Monitoring Plans, etc.
  • Optimize the structure and contents of the Monitoring SharePoint site.
  • Assist with audit plan development, site audit prep and site audit resolutions.
  • Oversee and manage the timely completion of monitoring document workflows in CTMS.
  • Review& approve monitor invoices for billable hours
  • Review & approve monitor expense reports Perform other duties as requested by Clinical Operations management.
  • Other duties as assigned.

Qualifications

  • BS/MS in life sciences or nursing preferred.
  • 5-10 years’ experience in clinical operations, preferably oncology, with at least 3 years of monitoring experience.
  • Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions to problems.
  • Excellent interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance.
  • Strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
  • Demonstrated knowledge of and experience with ICH/GCP for all US and ROW clinical trials.
  • Willing to travel up to 20%.
  • Computer proficiency including Microsoft Office applications.

 

Job Location: Remote

Please send resumes to talentacquisition@bostonbiomedical.com

Equal Opportunity Employer

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