Senior Clinical Trial Manager Location: Minneapolis, MN, US Job Family: Research & Development Country/Region: United States The Senior Clinical Trial Manager is a member of the clinical study team supporting all 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 complete site monitoring to comply with regulations and will ensure clinical activities comply with organizational SOPs and global regulatory requirements Major Areas of Accountability Manage and oversee pre-market and post-market clinical studies Complete clinical reports to support appropriate regulator requirements, e.g., ISO and FDA . Contribute to development and implementation of clinical strategy) Support and implement procedure process development and improvement Drive patient recruitment strategy development and execution Oversee site relationships internally and externally Oversee relationships with contract research organizations (CROs) and/or other vendors required to execute the clinical trial(s) 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 clinical site management Responsible for overseeing development of clinical databases, data management plans including data preparation, data validation activities, etc Develop monitoring plan and monitor sites for compliance with regulations, and support monitoring when requested Act as clinical representative on cross-functional product development team Attend professional conferences as required Author study reports Support Investigator Initiated Study Program (IISP) as assigned Process and review clinical study data using Good Clinical Practices (GCP) data-handling procedures and guidelines Conform with and all local Compliance Standards Conform with Coloplast Q/EHS Policy Other duties as assigned 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. Basic Qualifications 10+ years experience within clinical research, preferably with medical devices Bachelor's degree (preferably in health science or biotech area) Knowledge of and experience meetings with ISO, FDA, GCP, MedDev, and other applicable regulations and guidance for trial related activities. Experience with site activation, site management, monitoring and contract negotiation Ability to travel 20-30% Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 14,000 people and with products available in more than 143 countries, we are one of the worlds 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 on . Follow us on . Like us on . 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. 56000 #LI-CO #LI-Hybrid Nearest Major Market: Minneapoli Find similar jobs: EOE M/W/Vets/Disabled