Director, Monitoring & Site Management

1 month ago
Full-time
Lead
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

  • Provide day-to-day leadership and operational oversight of the Clinical Monitoring unit.
  • Support the planning, execution, and reporting of project-specific site selection and clinical monitoring processes.
  • Oversee ICH-GCP compliance issue resolution, SOP maintenance, QS document maintenance, and periodic site visits.
  • Partner with sponsors, researchers, and cross-functional project teams throughout the study lifecycle.
  • Represent Clinical Monitoring teams with internal stakeholders and external sponsors to address concerns and identify process improvements.
  • Ensure regulatory compliance, industry best practices, and organizational targets are met or exceeded.
  • Manage staffing, resource planning, work allocation, training, development, and performance management for monitoring teams.
  • Identify, procure, negotiate, and manage independent contractor services for Clinical Monitoring support.
  • Monitor contractor performance, costs, and compliance with corporate, sponsor, industry, and regulatory requirements.
  • Develop tools and support business development and project teams from bidding through sponsor reporting.

Requirements

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

Benefits

  • Remote home-based work arrangement.
  • Annual salary of $144,000 - $210,000.
  • Bonus eligibility.
  • Opportunity to work for a global, purpose-driven CRO focused on gastrointestinal disease research.
  • Work on meaningful clinical research that supports therapies for patients with GI diseases.

Interested in this position?

Apply directly on the company website

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