Patient Reported Outcomes Manager
AbbVie
3 months ago
Remote friendly (North Chicago, IL)
United States
$109,500 - $208,500 USD yearly
Clinical Research and Development
Job Description:
The Patient Reported Outcomes Manager reports to a Clinical Program Development (CPD) Program Lead and will be responsible for ensuring timely, adequate, cost effective business aligned standards, strategies and processes related to Patient Report Outcomes on behalf of the Clinical Development organization.
Responsibilities:
- Ensure compliance with applicable Corporate and Divisional Policies and procedures; provide project management and expert consultation supporting patient centered/PRO licensing and translation activities for all Therapeutic Areas within CPD.
- Own the Vault PRO Library repository for PROs, including licensing/permission details & terms, MSAs, translation requirements, training requirements, and electronic format requirements.
- Coordinate with PRO owners, Outsourcing, HEOR, Data Sciences, and clinical teams to implement PRO and ePRO during Study Start up (vendor contract initiation, translation management, milestones, timelines, deliverables).
- Provide strategic/technical expertise and training to CPD for PRO/ePRO activities during study start up; directly supervise PRO management associate(s).
Qualifications:
- Bachelor’s degree in a scientific field (or equivalent); minimum 6 years of global clinical research or project management experience.
- Minimum 2 years hands-on experience with Patient Reported Outcomes (PRO) or outcomes research.
- Strong core and technical competencies managing components of the PRO/ePRO process.
Required/Preferred Skills:
- Apply standard business procedures (SOPs) and understand global operations and regulatory/GCP context.
- Build effective working relationships across functions and geographic locations; demonstrated leadership and communication.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees; eligible for long-term incentive programs.
The Patient Reported Outcomes Manager reports to a Clinical Program Development (CPD) Program Lead and will be responsible for ensuring timely, adequate, cost effective business aligned standards, strategies and processes related to Patient Report Outcomes on behalf of the Clinical Development organization.
Responsibilities:
- Ensure compliance with applicable Corporate and Divisional Policies and procedures; provide project management and expert consultation supporting patient centered/PRO licensing and translation activities for all Therapeutic Areas within CPD.
- Own the Vault PRO Library repository for PROs, including licensing/permission details & terms, MSAs, translation requirements, training requirements, and electronic format requirements.
- Coordinate with PRO owners, Outsourcing, HEOR, Data Sciences, and clinical teams to implement PRO and ePRO during Study Start up (vendor contract initiation, translation management, milestones, timelines, deliverables).
- Provide strategic/technical expertise and training to CPD for PRO/ePRO activities during study start up; directly supervise PRO management associate(s).
Qualifications:
- Bachelor’s degree in a scientific field (or equivalent); minimum 6 years of global clinical research or project management experience.
- Minimum 2 years hands-on experience with Patient Reported Outcomes (PRO) or outcomes research.
- Strong core and technical competencies managing components of the PRO/ePRO process.
Required/Preferred Skills:
- Apply standard business procedures (SOPs) and understand global operations and regulatory/GCP context.
- Build effective working relationships across functions and geographic locations; demonstrated leadership and communication.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees; eligible for long-term incentive programs.