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Clinical Trial Manager

United States, Minneapolis Employment contract 108191.00 - 162287.00 USD / Year · Job Posted May 27, 2026
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Job Description

This position is member of the clinical study team supporting research activities. It is responsible for driving and managing clinical studies to support marketing and regulatory needs. This position will be a primary communication liaison between organization and customers participating as investigational sites on clinical studies. This position will also oversee project management and will delegate tasks to the clinical team members according to project plan. This position will comply with regulations and ensure clinical activities comply with organizational SOPs and global regulatory requirements.

Job Responsibility

  • Manage and oversee clinical studies from concept to study close out
  • Contribute to development of clinical strategy
  • including Clinical Evidence Plans (CEP) and Clinical Development Plans (CDP)
  • Develop clinical investigation plans for regulatory and marketing purposes
  • Develop and oversee project plans and budgets
  • Conduct initiation and site qualification visits
  • Responsible for managing site selection and activation (IRB, agreements negotiations and legal review, etc)
  • Responsible for overseeing development of clinical databases, data management plans including data preparation, data validation activities, etc
  • Responsible for clinical site management
  • Develop monitoring plan and monitor sites for compliance with regulations
  • Act as clinical representative on cross-functional product development team
  • Complete clinical reports to support ISO and FDA requirements
  • Support development of Clinical Evaluation Reports (CERs) as assigned
  • Process and review clinical study data using Good Clinical Practices (GCP) data-handling procedures and guidelines
  • Coloplast employees are required to conduct business to the highest ethical and professional standards
  • comply with applicable laws and regulations, the MedTech Code of Conduct, and company policies
  • Other duties as assigned

Requirements

  • 5-7 years of experience within clinical research, preferably with medical devices
  • Bachelor’s degree (preferably in health science or biotech area)
  • Experience with clinical trial management, specifically - site activation, site management, monitoring and contract negotiation
  • Experience with ISO, FDA, GCP, and/or MedDev regulations and guidance for trial-related activities
  • Ability to travel: 20-30%
  • Strong interpersonal and relationship-building skills
  • A collaborative mindset and strong motivation to make it easier for others to do great work
  • Ability to communicate with and drive efforts from external partners, such as health care providers
  • Self-driven with a structured and detail-oriented approach
  • Proficient in Microsoft Office applications including Word, Excel and PowerPoint

What we offer

  • Comprehensive medical, dental, and vision insurance plans
  • Company sponsored wellness programs and mental health resources
  • Paid leave of absence for qualifying events
  • Generous paid parental leave for both birthing and non-birthing parents
  • Competitive 401(k) plan with company match that vest immediately
  • Financial planning services
  • Corporate discount programs for goods and services
  • Generous paid time off
  • Flexible work hours
  • Flexible work arrangement options
  • Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement
  • Recognition programs including peer recognition, bonuses, awards, and special events
  • Team-building activities, volunteer opportunities, and company-sponsored events
  • Competitive compensation

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