This is an exciting opportunity for you to join a team boldly designing transcatheter mitral and tricuspid therapies from the ground up. Edwards' Transcatheter Mitral and Tricuspid Therapies team is deeply dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients' lives around the world.
The Sr. Representative, Clinical Operations is responsible for efficient processing and quality check of all study documents.
Conduct periodic audits of documentation and may participate in internal master file audits
Provide training and technical support for internal and external users for the trial master file
Review and ensure accuracy and completeness of clinical study files, enter into computerized tracking system, and file/scan for archive, for multiple clinical research trials
Assist with reviewing and processing clinical site and vendor payments
Other incidental duties and projects assigned by Leadership
HS Diploma or equivalent plus 4 years of related experience required.
Bachelor's Degree preferred.
Additional Talents and General Expectations:
Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery
Experience with an Trial Master File (TMF) software such as Veeva, CTMS (Clinical Trial Management System), etc. preferred
Excellent written and verbal communication skills and interpersonal relationship skills
Ability to work in a fast paced environment
Demonstrated problem-solving and critical thinking skills
Full knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation
Advanced problem-solving skills
Ability to manage confidential information with discretion
Completes tasks in resourceful and effective ways
Strict attention to detail
Ability to interact professionally with all organizational levels
Must be able to work in a team environment, including inter-departmental teams, with supervisory guidance provided as needed in the execution of routine tasks
General instructions given with assignment of new lines of work or complex special assignments
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards Lifesciences Corp