JOB DESCRIPTION JOB TITLE: Clinical Research Specialist, CRDM – HK & TW PAGE 1 OF 1 DEPARTMENT: Medtronic International, Ltd. Hong Kong REPORTING TO: Clinical Manager – CRDM, OA MAIN PURPOSE OF JOB Designs, plans, and implements clinical trials. Coordinates clinical study activities with Medtronic field personnel and study site to ensure compliance with protocol and overall clinical objectives. Ensures that the Company’s agreed quality standards are maintained with regard to its products, procedures, policies, operations and customer contact. MAIN JOB DUTIES / RESPONSIBILITIES Oversees, execute and monitors clinical trials. Designs protocols and patient record forms under supervision. Assures that clinical study activities are consistent with GCP, protocol, study objectives, local regulatory and corporate requirements. Monitors, analyses and/or interprets results of clinical trials. Serves as medical/scientific consultant to marketing and sales project teams and government regulatory agencies. Participates in project team meetings. Collaborates with various MDT departments and hospitals on the design, documentation, testing and implementation of clinical data studies. . Maintains a high level of professional expertise through familiarity with clinical literature. Determines methods and procedures on new assignments. Supports other projects and duties as requested by the Clinical Manager. Travels to field sites to supervise and coordinate clinical studies. Expects to have some out of hours and on-call work when required. 106750867 JOB DESCRIPTION JOB TITLE: Clinical Research Specialist, CRDM – HK & TW PAGE 2 OF 1 JOB QUALIFICATION REQUIREMENTS Knowledge / Education Tertiary education in medical/ science/ nursing or equivalent field PREFERENCES biological/ MBA qualification is preferred GCP Certified Job Experience Experience in clinical trial management approx. 2 yrs Experience in use and application of technical and regulatory standards, principles, theories, concepts, and techniques Experience in a medical environment is an advantage Skills / Competency Proficiency in Clinical Trial Management, GCP etc Good interpersonal communication skills Ability to absorb complex technical information Ability to communicate effectively in English and Chinese Excellent interpersonal and communication skills and be able to work across functions and countries Well organized; Ability to prioritize workload and cope under pressure (excellent time management skills) Self motivated, positive and possesses a “can do” attitude Accuracy and attention to detail; Structured handling of clinical study data and information Interest in medical technology, in particular pacing technology. Proficiency in Word and Excel and Experience with other Microsoft Office packages (Access) Support and act according to Medtronic core competencies of thinking, people, personal and results dimensions 106750867 Can work autonomously but is also a team player