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 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.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Visit us onColoplast.com

Watch the film.Follow us onLinkedIn

Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

61132
#LI-CO #LI-HYBRID