Clinical Affairs Supervisor

Lead, assist and conduct clinical studies from start up to closure. Assist with developing clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.) under supervision. Develop clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.). Assists management with departmental audits of clinical studies and procedures. Collaborate with project management, individual contributors and direct manager to establish and maintain study timelines Clearly demonstrate understanding of clinical study management/prioritization Manage all clinical tasks and deliverables to meet clinical timeline Ensure staff are delegated and trained appropriately and documented Assist with the management of studies by coordinating daily operations including methods, workflow and implementation of procedures. Establish KPI and benchmark metrics to measure responsible tasks, improve quality in the conduct of the studies, and lead continuous improvement initiatives Work with direct reports to execute assigned clinical trials including start up, subject recruitment & scheduling, collection of regulatory documents, conducting study visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, and providing IRB close-out reports. Responsible for identifying and escalating safety events Responsible for identifying and escalating protocol deviations Provide training to study staff and subjects. Collaborate effectively with peers and leadership across departments and can professionally interact/build relationships with FDA, IRB, and key opinion leaders. Up to 3 direct reports. Language Skills: Ability to read, analyze, and interpret general business correspondence and governmental regulations. Ability to write basic reports, emails, and transcribe notes either orally or handwritten Ability to effectively present information and respond to questions from managers, clients, customers, and the general public. Ability to effectively interact with international customers and their local customs as needed. Writes/reviews protocols, study reports, and other materials. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; and stoop, kneel, crouch, or crawl. The employee must be able to lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, and ability to adjust focus. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. The work environment may include collaboration with and/or supervision by remote employees, so excellent communication, independence, self-drive, and discipline skills are required. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Bachelor's degree in life sciences or a related field. A minimum of 10 years of clinical affairs and clinical operations experience in medical devices, Clinical Research Organization and/or pharmaceutical sectors. Comprehensive knowledge of clinical trial design, regulatory requirements, GCP standards, quality assurance, and risk management. Must hold an active license to practice healthcare and able to act as Principal Investigator (RN, MD, Pharm.D ) Demonstrated ability to lead and manage clinical teams globally. Exceptional communication and interpersonal skills, facilitating effective collaboration across different cultures. Strong project management capabilities, underpinned by meticulous organizational skills and an unwavering attention to detail. Proficiency in relevant clinical trial software and data management tools. Fluency in English; proficiency in additional Asian languages is a notable advantage. (Reading, Writing, Dialect) Familiarity with continuous glucose monitoring devices and diabetes management is a plus. Pro-active, energetic, self-assured professional with high personal integrity and ability to develop and maintain good interpersonal relationships Analytical, strategic thinker with leadership ability and style that demonstrates professionalism and establishes respect. Excellent organizational skills and attention to detail. Experience in continuous glucose monitoring (CGM) is a plus.