Business Operations Manager

3 weeks ago


Addlestone, Surrey, United Kingdom Pharmiweb Full time
About the Role

We are seeking a highly skilled Business Operations Manager to join our Clinical Operations Excellence team. As a key member of our team, you will be responsible for managing and leading the day-to-day operations within Study Start Up to ensure timely completion of goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.

Key Responsibilities
  • Manage and lead the day-to-day operations within Study Start Up to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
  • Oversight of SSU activities from receipt of a potential site list to site activation including CDA and questionnaire collection, site selection, IRB/EC submissions, IMP Release and other site activation requirements.
  • Driving site activation timelines to ensure timely completion and assist with mitigations and escalations to ensure milestones remain on track.
  • Leading the preparation of study level essential document templates.
  • Aiding in the preparation of content for Regulatory submissions.
Requirements
  • Solid knowledge of clinical trial conduct, including, multi-center, global trials.
  • Strong knowledge of ICH/GCP guidelines and regulatory requirements.
  • Requires proven project management skills and leadership ability.
  • Experience in pharmaceutical related drug development.
  • Excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
  • Good command in English.
What We Offer
  • A challenging and diversified job in an international setting.
  • Opportunity and support for continuous development.
  • Inspiring work climate.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.



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