Coloplast Corp

Clinical Trial Manager

Coloplast Corp • $108K — $162K *
Minneapolis, MN 55407In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 5-7 years of clinical research experience, ideally with medical devices
  • Bachelor's degree in health science or biotech
  • Experience managing clinical trials, including site activation and monitoring
  • Familiarity with ISO, FDA, GCP, and relevant MedDev regulations
  • Ability to travel 20-30%

Responsibilities

  • Oversee clinical studies from start to completion
  • Develop clinical strategy including Clinical Evidence and Development Plans
  • Create investigation plans for regulatory and marketing uses
  • Manage project plans and budgets
  • Conduct initiation and site qualification visits
  • Direct site selection and activation processes
  • Ensure compliance through development and monitoring of clinical databases

Benefits

  • Comprehensive medical, dental, and vision insurance
  • 401(k) plan with immediate vesting and company match
  • Generous paid time off and flexible work arrangements
  • Opportunities for career advancement through training and mentorship
  • Recognition programs for achievements and contributions
  • Supportive company culture with a focus on community engagement
Full 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.

Major Areas of Accountability
  • 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 job duties as assigned

Basic Qualifications
  • 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%


Required Knowledge, Skills and Abilities
  • 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
    At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Here is some of what you can expect:
    • Health and Wellness: Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to company sponsored wellness programs and mental health resources, paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.
    • Financial Security: A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.
    • Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
    • Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
    • Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
    • Community and Culture: A supportive work environment where everyone feels valued, and has a sense of belonging. Participate in team-building activities, volunteer opportunities, and company-sponsored events. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
    • Competitive Compensation: The compensation range for this position is $108,191 - $162,287. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.


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About Coloplast Corp

Coloplast Corp is a Danish multinational company that develops, manufactures and markets medical devices and services related to ostomy, urology, continence, and wound care. The company was founded in 1957 and is headquartered in Humlebaek, Denmark. Coloplast operates globally with production facilities in Denmark, Hungary, China, and the United States. The company's products are sold in more than 140 countries. Coloplast is committed to improving the quality of life for people who have intimate healthcare needs. The company's mission is to make life easier for people with intimate healthcare needs by developing products and services that make a difference to their lives.
Learn more about Coloplast Corp
Size
12,000 employees
Industry
Healthcare
Founded
1978
* Ladders Estimates

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