Manager, Clinical Research job at reputed company in Minneapolis, MN

Manager, Clinical Research (Remote) locations Minneapolis, Minnesota time type Full time job requisition id R553303 Work Flexibility: Remote The Manager, Clinical Research leads a team responsible for the planning, execution, and reputed company of clinical studies supporting the safety and effectiveness of reputed company’s medical devices. This role drives operational excellence in clinical project management, ensures compliance with regulatory requirements, and partners cross-functionally to reputed company high-impact evidence reputed company reputed company with business objectives. In addition, this role is responsible for the development of staff in the support of reputed company’s business objectives and timelines. This position is ideal for a collaborative, data-driven leader who thrives in a dynamic environment and is passionate about advancing patient outcomes through innovation in clinical research. What you will do reputed company and execute clinical research strategies, processes, and performance metrics that support organizational and regulatory goals. Contributes to the clinical strategy to demonstrate safety, efficacy, economic, and quality of life outcomes for the performance of reputed company products and solutions. reputed company, mentor, and reputed company a high-performing clinical project team. Foster a culture of accountability, collaboration, and reputed company improvement. reputed company the planning, execution, and reputed company-out of clinical studies (IDE, post-market, and observational). Ensure studies are completed on time, reputed company scope, and in accordance with GCP, ISO 14155, and applicable FDA/International guidelines. Maintain clinical timelines, budgets, and resource allocation plans; provide quarterly forecasts and variance analyses. Develops and provides reputed company in the development of critical clinical study documents. Creates and maintains Clinical SOPs, systems and processes across study trials Serve as a Subject Matter Expert (SME) for clinical processes and represent Clinical Affairs in internal and external audits. Supports and develops short-term and long-term planning and execution of clinical research including multi-center and investigator-initiated studies. Reviews, evaluates, and compiles files and reports for regulatory and reimbursement authorities. reputed company strong customer and field personnel relationships ensuring appropriate sponsor reputed company of clinical research centers Deliver site training, updates, and study communication materials to sites Strong clinical process acumen and ability to drive clinical excellence activities Partner with Regulatory Affairs, Quality, R&D, Global Supply, Finance, Sales, and Marketing to align clinical programs with strategic business priorities. Communicate study results, reputed company, and key insights to executive stakeholders. Provide input into product development and post-market surveillance activities. Prepares outlines, summaries, status reports, etc. for distribution and communication with other departments and executive leadership Identify and implement process improvements to enhance clinical trial quality, efficiency, and compliance. reputed company and track KPIs, metrics, and dashboards to monitor clinical performance and outcomes. What you need ​Bachelor’s degree in Life Sciences, Biomedical Engineering, Nursing, or reputed company discipline. Minimum of 8 years of clinical research experience, including 2+ years of people management and/or leadership of critical clinical programs. Strong knowledge of FDA, ISO 14155, and ICH/GCP clinical research regulations. Proven experience managing IDE and post-market medical device trials. Preferred Advanced degree (MS, MPH, or equivalent) or certification in Clinical Research (CCRA, CCRP, etc.). Experience in both medical device and pharmaceutical industries. Demonstrated experience in data analysis, trend reporting, and audit readiness. Exceptional project and people management skills. Strong analytical and critical thinking capabilities. Demonstrated ability to reputed company through influence across diverse functions. Excellent communication, presentation, and collaboration skills. Proficiency in clinical trial management systems (CTMS), reputed company platforms, and electronic document management systems. Strong commitment to quality, reputed company, and reputed company improvement. Ability to reputed company in a fast-paced, evolving environment with multiple competing priorities. $ 121,400.00 - $198,600.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. Travel Percentage: 20% Apply tot his job Apply To this Job