Sorry, this job is no longer accepting applications. See below for more jobs that match what you’re looking for!

Senior Representative, Clinical Operations Transcatheter Mitral And Tricuspid Therapies (Tmtt)

Expired Job

Edwards Lifesciences Corp Irvine , CA 92606

Posted 2 months ago

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.

Job Functions:

  • 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

#LI-NJ1

#AS

Required Education/Skills/Experience:

  • 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

See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Manager Clinical Trial Master File / Clinical Operations Transcatheter Mitral And Tricuspid Therapies (Tmtt)

Edwards Lifesciences Corp

Posted 3 days ago

VIEW JOBS 11/17/2018 12:00:00 AM 2019-02-15T00:00 Edwards Lifesciences has a unique opportunity to play a critical role in Transcatheter Mitral & Tricuspid Therapies (TMTT) clinical study execution. Internally titled as the Manager, Clinical Operations - the Trial Master File Manager will lead the team responsible for eTMF, study training matrices and study supplies while maintaining and driving high levels of accuracy and compliance in a fast-paced, complex environment. The ideal candidate will be a dynamic leader and team player who has successfully managed a team responsible for the eTMF in a cardiovascular / medical device organization. Depending on experience level, we are open to hiring Clinical Trial Master File (TMF) at the Associate Manager or Manager level. This role is based in Irvine, California Essential Job Functions: * Lead team responsible for all aspects of the eTMF (electronic trial master file) including accuracy, completeness and compliance of documentation in multiple clinical research trials. * Lead team in development, maintenance and management of internal study training matrices and tracking of respective training records. * Lead team with production, distribution and tracking of study materials (e.g. study binders and patient recruitment materials) to clinical sites * Work with cross functional partners to create and communicate detailed metrics reporting (e.g. eTMF and internal study training completion) to drive study compliance. * Lead projects from inception through completion, including developing and/or scheduling key milestones, securing and allocating resources. * Develop multiple competing timeline assessments, identify and resolve risks that deviate from plan, and collaborate with clinical stakeholders in order to meet key study milestones and deadlines. * Assess knowledge and/or quality gaps of staff and determine appropriate training plans and/or needs. * Mentor, coach, and train team members. #LI-MO1 #MI Required Education/Skills/Experience: * Bachelor's Degree in related field. * 10 years of related experience in Clinical Trials required. 8 years required for Associate Manager level. * Strong People Management Skills with the ability to lead and manage a diverse team with successful experience supervising subordinates. * Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), Veeva eTMF (electronic Trial Master file) * Travel up to 10% Preferred: * Industry experience with Class II & III medical devices preferred. * Experience obtained from sponsor run studies in Med Device, CRO and Pharma industries Additional Talents and General Expectations: * Proven detailed project management experience with demonstrated ability to influence change. * Demonstrated strong problem-solving, process improvement, analytical, and collaborative skills. * Comprehensive written and verbal communication, facilitation, presentation and follow-up skills. * Meticulous organizational skills and the ability to meet tight deadlines in an environment of competing priorities. * Extensive knowledge of international regulations of Good Clinical Practice (GCP) * Extensive knowledge and understanding of diverse and applicable regulations and standards relevant to medical devices (e.g., 21 CFR Part 11/50/54/56/801/803/806/807/820/812/814/821/822, ISO 14155; ICH GCPs) * Extensive knowledge of clinical trials and regulatory requirements * Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization. Edwards Lifesciences Corp Irvine CA

Senior Representative, Clinical Operations Transcatheter Mitral And Tricuspid Therapies (Tmtt)

Expired Job

Edwards Lifesciences Corp