Manager, Monitoring & Site Management

3 weeks, 5 days ago
Full-time
Senior
Project and Program Management
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
251-1K
Founded 1986

Description

  • Lead the day-to-day delivery of the Clinical Monitoring capability, with a focus on European CRAs.
  • Identify, develop, plan, monitor, approve, and report on project-specific processes and services related to site selection and clinical monitoring.
  • Support resolution of ICH-GCP compliance issues and global project harmonization, including SOP and QS document maintenance.
  • Coordinate periodic site visits and work with IT support to meet sponsor requirements on time.
  • Represent Clinical Monitoring teams with internal partners and external sponsors to address concerns, identify improvements, and integrate new technologies and processes.
  • Ensure regulatory compliance, industry best practices, and organizational goals and targets are met or exceeded.
  • Manage Clinical Monitoring team members through staffing, work allocation, resource planning, training, development, expense management, engagement, and performance management.
  • Identify, procure, and manage independent contractor services for Clinical Monitoring operations, including recruitment, contract negotiation, compliance, training, cost monitoring, and performance management.
  • Develop tools and provide expertise to support project teams and business development across the clinical study lifecycle from bidding through sponsor reporting.

Requirements

  • College diploma or university degree in a relevant field, with Health Sciences or Life Sciences preferred.
  • SoCRA and/or ACRP certification or designation preferred.
  • 4-6 years of related experience plus substantial ongoing training.
  • Experience managing CRA staff.
  • Ability to provide 1:1 training and/or mentorship to colleagues in meetings or individual settings.
  • Ability to work in a remote global capacity.
  • Strong knowledge of regulations and guidelines related to clinical monitoring and GCP.
  • Demonstrated leadership skills.
  • Strong verbal, written, and organizational skills.
  • Ability to manage multiple tasks and meet deadlines in a dynamic environment.

Benefits

  • Full-time, permanent role.
  • Remote, home-based working arrangement.
  • Annual salary range of €76,500 - €127,500.
  • Bonus opportunity.
  • Opportunity to work in a global CRO focused on gastrointestinal disease research.
  • Chance to contribute to scientific research, technology, and patient-impacting therapies.

Interested in this position?

Apply directly on the company website

Apply Now

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