Job Description
o What does your group do? Broad overview, our team handles the logistics of screening patients for our clinical trials. We look at CT and echo reads and also look at the pt’s medical/clinical history to confirm that the pt meets all the inclusion/exclusion criteria to be in our trial. If everything looks good we then put together PPT slides to present the pt to the case review board who then makes the final decision on whether the pt is accepted to the trial or not.
o Does your team use any specific technology/software you want us to look out for? The candidate should have experience with Microsoft office, with an emphasis on Excel. We would prefer the pt have experience using pivot tables and creating graphs and charts on Excel.
o What would standout for you in a resume? Having experience with Excel and having some sort of research or clinical experience would be one of the things we’re looking for. Being a team player and being able to work well with others would be important as well.
o What does the ideal candidate need to possess to be successful in this role? Some sort of research/clinical/medical background, experience with excel, team player, works well with others, great communication skills, able to work in a fast paced environment.
More on this position:
o What will a typical workday look like? The candidate’s duties will mostly include helping file PPTs/PDFs/etc. into folders to keep us audit-ready, creating email templates for us to communicate with sites, working in excel spreadsheets to keep track of patient screening, creating reports regarding screening numbers, helping create PPT slides for case review, and other miscellaneous tasks.
The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide.
The Clinical Operations Analyst will be a key contributing member of the dynamic Case Review Team, providing timely logistical support, analysis and tracking during patient screening and procedural case reviews for multiple transcatheter heart valve clinical trials.
Essential Job Functions/Key Responsibilities:
• Prepare templates for case review, assist with logistics and file case presentations
• Enter case review data into excel spreadsheets
• Perform quality/audit checks of case review data
• Creation of complex excel spreadsheets to track/analyze case review and CT data and metrics
• Assist with creation of templates for procedural case reviews
• Other miscellaneous case review tasks
Minimum Requirements:
• Bachelor's Degree and 3 years of previous hands-on clinical research related experience or experience in a medical related field with medical terminology knowledge
Preferred Qualifications:
• Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery
• Excellent written and verbal communication skills and interpersonal relationship skills
• Ability to work in a fast-paced environment and work flexible hours to meet the pace and demand of case review
• Demonstrated problem-solving and critical thinking skills
• Full knowledge and understanding of company 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
Job Tags
Remote job, Contract work, Worldwide, Flexible hours,