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Clinical Research Associate - Field Management - Detroit Michigan

Company: Novo Nordisk
Location: Detroit
Posted on: May 7, 2021

Job Description:

About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a difference? The Position Takes ownership to deliver upon near-term North American Clinical Operations (NACO) goals, including successful delivery of studies within the clinical trial portfolio. Maintains responsibility for quality, performance, regulatory compliance and patient safety related to managing assigned clinical trial sites, document handling and trial product handling. Has responsibility for all monitoring activities (on-site and off-site) of assigned clinical trial sites according to the Monitoring Plans, International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines. Relationships Reports to a Manager (or above) within NACO. Manages mutually beneficial relationships with external partners relevant to the design and implementation of clinical trials and improvement/innovation projects for NACO and Novo Nordisk (eg clinical trial site staff, clinical research vendors). Manages relationships positively with multiple internal stakeholders relevant to the design and implementation of clinical trials and improvement/innovation projects for NACO & Novo Nordisk (eg, across NACO, CMR, International Operations (IO), HQ R&D, & Commercial). Provides excellent customer service and builds strong working relationships with investigative sites and internal cross-functional partners. Essential Functions + Delivers all relevant services/tasks in support of the planning and execution of quality driven clinical trials, in line with established targets and including communication of updates + Verifies Serious Adverse Events (SAE) reporting according to trial specification and ICH-GCP guidelines + Ensures proactive risk identification and mitigation planning for assigned clinical trial sites + Drives recruitment/retention follow up with clinical trial sites to track and support enrolment strategies + Attends on-site audit, prepare for and follow-up on audits and inspections, collaborates and implements Corrective Action Plans (CAP) with investigative sites with oversight from Clinical Site Lead (CSL) and/or Trial Manager (TM) + Shares information, collaborate and provide relevant input and guidance to other areas within NACO, CMR, and Global partners + Demonstrates technical proficiency within responsible areas, staying up to date on new practices and builds knowledge of emerging trends and advances within area + Contributes to local or increasingly complex improvement/innovation projects for the department (subset) of NACO and/or as part of a global team and as aligned to a business case, goals and/or future aspirations + Contributes to a continually changing environment, supporting a future-focused approach, leveraging competencies, tools and technology + Contributes actively to relevant teams as assigned + Contributes to local or increasingly complex improvement/innovation projects for the department (subset) of NACO and/or as part of a global team and as aligned to a business case, goals and/or future aspirations + Contributes to a continually changing environment, supporting a future-focused approach, leveraging competencies, tools and technology Physical Requirements 50-75% overnight travel required. Qualifications + A Bachelor's degree (science-related discipline preferred) and a minimum of 2 years of on-site monitoring experience required; or, a Registered Nurse degree and a minimum of 3 years of on-site monitoring experience required + A minimum of 4 years of clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting required + Demonstrated understanding of medical terminology and ICH-GCP principles and the application of those principles to trial planning and conduct of clinical trials + Demonstrated computer skills (MS Office, MS Project, MS PowerPoint) + Excellent communications skills (verbal, written, presentation) in English + Demonstrated collaborative and stakeholder management skills Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Keywords: Novo Nordisk, Detroit , Clinical Research Associate - Field Management - Detroit Michigan, Executive , Detroit, Michigan

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