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Biomapas

A complete spectrum of Clinical Research, Regulatory Affairs, Pharmacovigilance and Medical Information solutions.

Clinical Operations Lead

Clinical OperationsClinical OperationsFull TimeRemoteSeniorTeam 201-500H1B No SponsorCompany SiteLinkedIn

Location

Poland

Posted

3 days ago

Salary

0

Seniority

Senior

Postgraduate Degree3 yrs expEnglishGoogle Cloud Platform

Job Description

Clinical Operations Lead

Biomapas

• Oversight of (a group of) study CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines • Monitoring support visits (Accompanied site visits), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards • Develop training materials and study tools for sites and CRAs, including monitoring plans • Develop and implement enrolment and recruitment strategies together with clinical project team • Support clinical project team by providing oversight of study deliverables related to other functions (e.g. Data Management, TMF Operations, etc.) • Proactive management of site and country performance (recruitment, data collection, document collection, TMF review, timely update of Biomapas/sponsor CTMS by the study CRAs etc.) and inform clinical project team on progress • Oversee regional startup and feasibility activities • Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study • Assist in vendor management activities as required per project • Perform review of visit reports for quality, compliance and appropriate site management • Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan

Job Requirements

  • Bachelor’s or Master’s Degree in Medicine, Pharmacy or Life science
  • 3 years experience in Clinical Lead role
  • Fluent written and spoken English language
  • Good coordination skills
  • Attention to detail, time-management and problem-solving skills
  • Strong organization and analytical skills

Benefits

  • Professional growth and career opportunities
  • International team and environment
  • Bonus based on annual performance
  • Personal accident and business trip insurance
  • Additional health insurance
  • Remote/home based
  • Complimentary health and wellness benefits, such as influenza vaccines
  • Rewarding referral policy
  • Workplace establishment allowance (fully remote)
  • Team building, global meetings, B active events

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