The Patient Reported Outcomes (PRO) Management Associate III is a pivotal operational lead responsible for the strategic execution of Clinical Outcomes Assessment (COA) deliverables. This role ensures that the patient's perspective is accurately captured and preserved through rigorous management of licensing, translation, and implementation workstreams. By serving as the central authority for PRO requirements, the Associate III accelerates study start-up timelines and upholds the scientific integrity of global clinical programs.
location: North Chicago, Illinois
job type: Contract
salary: $45.00 - 52.99 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Operational Lifecycle Management: Lead the "chain of custody" for all COA assets, from initial licensing through complex linguistic validation and final electronic implementation.
- Regulatory Documentation: Direct the compilation and finalization of comprehensive COA Binders within Veeva Vault, ensuring absolute synchronization with the Trial Master File (TMF) and Global Clinical Practice (GCP) standards.
- Strategic Interfacing: Serve as the primary liaison between Therapeutic Area leads, Data Sciences, and external PRO owners to resolve licensing bottlenecks and optimize vendor contract initiation.
- Systems & Data Stewardship: Manage high-volume metadata and project tracking within Smartsheets and Veeva Vault to provide leadership with quantifiable metrics on trial readiness and cost-saving initiatives.
- Process Optimization: Provide technical expertise to study teams regarding ePRO requirements, training protocols, and electronic format specifications to ensure seamless data collection at the site level.
qualifications:
Required Skills:
- Bachelor's degree in a scientific field (or Associate degree with equivalent specialized experience).
- Minimum of 4 years in Clinical Research or Project Management.
- Minimum of 1 year of direct, hands-on experience with Patient Reported Outcomes (PRO) or Outcomes Research.
- Proven expertise in the end-to-end clinical trial process and how COA delays impact study timelines.
- Mastery of Project Management principles and the ability to manage high-volume administrative structures.
- Advanced proficiency in Veeva Vault and Smartsheets.
- Master's degree in a scientific or healthcare-related field.
- Experience building cross-functional relationships across global geographic locations.
skills: Project Management, Health Economics, Good Clinical Practice (GCP), Trial Master File (TMF), Electronic Trial Master File (eTMF), Patient Reported Outcomes (PRO), HEOR Endpoints, Veeva Vault
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
