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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