Clinical Operations

Job Title: Clinical Operations

Pay Rate: $45 to $50/Hr

Duration: 12 months

Location: Remote (Work schedule - 9 am to 5 pm PST)

Our Client is a Global medical device Manufacturer.

We are looking for a Clinical Operations who 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

• Oversee daily requests and support for the technical platforms used for case planning activity in partnership with the field team, case planning, sales operations, information technology and external stakeholders.
• Responsible for collaborating with the case planning team to plan, schedule, track, manage and achieve defined goals.
• Responsible for external stakeholder communication and support for the case planning workflow process.
• Coordinate project management platform tasks and process standardization.
• Drive timely and accurate imaging submissions from commercials sites to allow for internal review by the case planning team.
• Identify issues and provide recommendations for process improvement.
• Provide high quality, timely responses to the sales organization to meet information and reporting needs. Communicate complex logic and analysis in a manner that is easily understandable.
• 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,
• 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,
• Assist with the creation of templates for procedural case reviews,
• Other miscellaneous case review tasks,

Must Have Skills:

• Experience with Microsoft Office, especially Excel pivot tables/charts/graphs.
• Clinical/Medical/Research Experience.

Requirements:

• Bachelor's Degree or Equivalent in Computer Science, Engineering, Business or related field, 2-4 years of patient screening experience in the setting of a clinical trial Required.
• Should have experience with Microsoft Office, with an emphasis on Excel. We prefer the candidate to have experience using pivot tables and creating graphs and charts on Excel.
• 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.
• Team player, works well with others, great communication skills, able to work in a fast-paced environment.
• Good computer skills in Microsoft Office Suite, including Word, Excel, and PowerPoint, and related system(s).
• Good written and verbal communication skills and interpersonal relationship skills.
• Good problem-solving, organizational, analytical, and critical thinking skills.
• Moderate understanding of medical terminology as it relates to clinical studies.
• Ability to manage confidential information with discretion.
• Strict attention to detail.
• Ability to interact professionally with all organizational levels.
• Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects.
• Ability to build productive internal/external working relationships.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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.
• Proven expertise in the MS Office Suite, Adobe, and the 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 our 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.
• 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 are given with the 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 the environment and prevention of pollution under their span of influence/control
• Medical terminology knowledge in the structural heart space.