Senior Clinical Trial Leader

JOB TYPE: Full Time, Employee JOB CATEGORY: Quality Assurance/Safety CITY: Northridge STATE: CAAbout Medtronic Benefits and Total Rewards It's challenging. It's energizing. It's rewarding. That's why our nearly 38,000 employees have chosen to spend their careers at Medtronic, a global leader in medical technology, providing lifelong solutions for people with chronic disease. Today, every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. Join us in our mission to alleviate pain, restore health and extend life, and discover why FORTUNE magazine named us one of the "100 Best Companies to Work For" eight of the last 10 years. Senior Clinical Trial Leader Req. # 62704Position Description The Clinical Trial Leader is responsible for overseeing all clinical activities related to one or more clinical studies and performing/managing the daily operations associated with support of the assigned studies.  This position should be able to function with minimal supervision, handling various clinical study assignments, and collaborating with cross-functional colleagues in resolution of issues.  The Clinical Trial Leader may have Clinical Research Associates and/or Clinical Research Assistants as direct reports. Position Responsibilities • Provide study program development and management oversight to assure successful conduct of assigned clinical studies consistent with applicable regulations, guidelines and policies. This may involve multiple regulatory requirements, based on location of study conduct. • Provide oversight of monitoring activities and operations functions in assigned locales, as well as technical training/feedback to study site personnel and team members. Liaison to clinical sites, CRO and management, in-house Program Team, and U.S. Field Team (as applicable). Interface with cross-functional groups including Operations, Customer Service, R&D, Manufacturing, Sales, Software Development, Marketing, Regulatory Affairs, Legal, and Finance. • Determine obstacles, identify solutions, and implement plans in collaboration with the study team to meet study objectives, scope and schedules. Enlist support and specify tasks for various clinical and project team members to assure that study deliverables and timelines are met. • Research, prepare and present study management issues to Clinical Research management in a timely and proactive manner. Participate in issue resolution and execution. • Perform and oversee site activation activities. Participate in development of study protocols, detailed training plans and materials; interface / train investigators, site staff, and CRO staff as applicable. Oversee set-up and maintenance of accurate study budgeting, status tracking and product accountability. Coordinate clinical activities based on site and study needs and perform other duties as assigned. Ensure adequate monitoring of study, documentation and resolution of issues, and preventative/corrective action implementation to prevent reoccurrence. This will usually involve oversight of CRO monitors, but may require hands-on intervention in cases. • Collaborate with cross-functional team/CRO in evaluation of safety data, device reconciliation, and data analysis. Basic Qualifications • Bachelor’s degree • 5 years work experience. • Project Management experience in a clinical setting. • Demonstrated people management skills.   • Advanced written and oral communications skills, with proficient knowledge of medical terminology. • Ability to present complex technical products and processes to physicians in a clear, direct manner.   • Demonstrated ability to work effectively on cross-functional teams. • Strong knowledge of monitoring functions and clinical research study design. • Advanced computer literacy. • High attention to detail and accuracy and ability to manage multiple tasks. • Strong prioritization, organizational, and problem solving skills. • Excellent interpersonal communication skills.  Ability to work independently, with positive flexible outlook. • Ability to present in a professional manner and appearance. Desired/Preferred Qualifications • Preferred education in engineering, life sciences or related medical/scientific field.• Masters degree will substitute for 1 year of experience.  A Ph.D. or MD will substitute for 2 years of experience. • RN preferred• Work Experience directly supporting clinical research or similar experience in a medical/scientific area• Experience working with European investigators. • Nursing/clinical work history preferred. • Clinical Operations exposure. • Experience interfacing with CRO teams. • OUS clinical trial management experience. • Multi-lingual. • CDE (certified diabetes educator) or CCRA certification (Certified Clinical Research Association) or equivalent preferred • Expertise with GCPs and regulatory compliance guidelines for clinical trials • Proficiency with writing reports, business correspondence and procedure manuals • Finance and budgeting knowledge. • Knowledge of Diabetes • Self-starter who is willing to work very independently and is self directed   To Apply: Click Apply Now to route your resume directly to the hiring department. No agencies or phone calls, Please Medtronic is an equal opportunity employer committed to cultural diversity in the workforce. www.medtronic.com/careers   Click here to see other Medtronic opportunities  Email this Job to a Friend