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Manager, Monitoring & Site Management (CRA Team)

1 day, 8 hours ago
United Kingdom, Germany, Hungary, Ireland, Poland, Romania
Full-time
Lead
Operations Manager
Project and Program Management
Apply Now
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
501-1000
Founded 1986
View All Jobs 26

Description

  • Lead day-to-day delivery of the Clinical Monitoring capability, with a focus on European CRAs.
  • Plan, manage, monitor, and improve project-specific processes for site selection, clinical monitoring, ICH-GCP issue resolution, and global project harmonization.
  • Maintain SOP and quality-system documentation, coordinate periodic site visits, and partner with IT to meet sponsor requirements.
  • Ensure clinical monitoring activities meet regulatory requirements, industry best practices, and organizational targets.
  • Represent Clinical Monitoring teams with internal partners, sponsors, and research sites to resolve concerns and identify improvements.
  • Manage Clinical Monitoring staff, including staffing, work allocation, resource planning, training, development, engagement, expenses, and performance management.
  • Source, contract, train, and manage independent Clinical Operations Leads, including cost and performance monitoring.
  • Develop clinical, site, compliance-monitoring, and performance tools to support project teams and business development from bid through sponsor reporting.

Requirements

  • College diploma or university degree in a relevant field; Health Sciences or Life Sciences preferred, or SoCRA and/or ACRP certification/designation.
  • 4–6 years of related experience plus substantial ongoing training.
  • Experience managing CRA staff.
  • Ability to train and mentor colleagues individually and in group settings.
  • Strong knowledge of clinical monitoring regulations, guidelines, and Good Clinical Practice (GCP).
  • Demonstrated leadership skills and a collaborative, customer-service-oriented, solutions-focused approach.
  • Strong verbal, written, and organizational skills.
  • Ability to manage multiple priorities and meet deadlines in a dynamic environment.
  • Ability to work remotely in a global capacity.
  • Must reside in Germany, the United Kingdom, Ireland, Poland, Hungary, or Romania.

Benefits

  • Home-based work arrangement.
  • Education reimbursement for full-time employees.
  • Monthly cell phone and remote-work allowance, subject to role eligibility.
  • One-time home office setup allowance.
  • Work-from-another-location program for up to four weeks per year.
  • Flexible summer hours from May through September.
  • Employee referral incentive.
  • Access to mentorship, leadership development, social events, and eligibility for the Alimentiv Trust based on tenure.

Interested in this position?

Apply directly on the company website

Apply Now

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