Clinical Operations Analyst Jobs

Experience in healthcare/case management systems is a plus

Degree in any of the following fields: occupational therapy, nursing, social work, case management, or related wellness field

Communicate domain knowledge and clinical findings to stakeholders and colleagues

Developing novel program design to address program needs based on clinical experience and data

2+ years of hands-on clinical or wellness experience in a 55+ population

Basic knowledge of research methodologies in controlled and observational settings, including statistics and data analysis methods

Experienced in developing and executing plans including, but not limited to, study goal, milestone, and risk management plans

Must have experience creating and managing complex study budgets with a focus on financial management of vendors

Strong vendor management experience, from selection to management, and issue escalation. Experience developing and ensuring adherence to scope of work

Collaborate with Data Management to oversee data quality issues (query and data quality management and resolution)

Oversee CRO TMF management and maintenance checks

BA/BS in a relevant scientific discipline or equivalent combination of education/experience in science or a health-related field is required

Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) preferred

Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery

Good written and verbal communication skills and interpersonal relationship skills

Substantial knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation

Ability to manage confidential information with discretion

Conduct periodic audits of documentation and may participate in internal master file audits

•Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) preferred

•Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery

•Good written and verbal communication skills and interpersonal relationship skills

•Ability to manage confidential information with discretion

18+ Month Assignment (possibility of extension)

•Conduct periodic audits of documentation and may participate in internal master file audits

•Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) preferred

•Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery

•Good written and verbal communication skills and interpersonal relationship skills

•Ability to manage confidential information with discretion

18+ Month Assignment (possibility of extension)

•Conduct periodic audits of documentation and may participate in internal master file audits

Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) preferred

Top three non-negotiable technical skills and years of experience required for candidate.

High level of detail oriented, lots of data entry and templates

Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery

Good written and verbal communication skills and interpersonal relationship skills

Substantial knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation

Solid understanding and knowledge of principles, theories, and concepts relevant to clinical trial management.

3 years of previous hands-on clinical research experience

Good computer skills in the usage of MS Office Suite including MS Project and excellent Excel skills required.

Excellent written and verbal communication skills and interpersonal relationship skills

Solid knowledge of human anatomy and physiology

Good problem-solving, organizational, analytical, and critical thinking skills