Hourly Rate: $46-50/hr (medical benefits available at a cost)
Join a collaborative, fast-moving Clinical Program Development team where your work directly supports clinical trials and patient-centered outcomes. This is a high-impact, data-driven role focused on keeping studies on track and ensuring seamless PRO/ePRO execution.
The Patient Reported Outcomes Manager is responsible to drive and manage deliverables with the PRO/ePRO process from onset of PRO licensing through PRO owner requirements. Contributes patient reported outcome expertise to ensure PRO/ePRO licensing is executed on time to minimize delays during study Start-Up and identify potential trial specific cost savings. The PRO manager will serve as the central point of contact for therapeutic areas within Clinical Program Development (CPD).
Responsibilities:
- Provide expertise and consultation supporting patient centered/PRO licensing and translation activities for all Therapeutic Areas within Clinical Program Development (CPD).
- Serve as the owner of the Vault PRO Library which is a repository for PROs and includes licensing and permission details & terms; MSAs; translation requirements; training requirements; electronic format requirements; etc.
- Interact with PRO owners, Outsourcing, HEOR, Data Sciences and the clinical teams to drive and facilitate the PRO and ePRO implementation with respect to vendor contract initiation, translation management, project milestones, timelines, and deliverables during Study Start up.
- Provide strategic & technical expertise and training to the CPD organization in support of PRO/ePRO activities during study start up.
Qualifications:
- Bachelor's Degree in a scientific field or equivalent with relevant experience is acceptable A minimum of 4 years of global (direct or peripheral) clinical research or project management experience.
- Must have knowledge and minimum 1-year hands on and relevant experience with Patient Reported Outcomes or outcomes research.
- Must have demonstrated a high level of core and technical competencies.
- Competent in application of standard business procedures (Standard Operating Procedures) and understand the global environment from an operations and regulatory/ (GCP) Good Clinical Practices) perspective. Must have experience building effective working relationships across functions and geographic locations.
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance Learns, fast, grasps the 'essence' and can change the course quickly where indicated Raises the bar and is never satisfied with the status quo Creates a learning environment, open to suggestions and experimentation for improvement Embraces the ideas of others, nurtures innovation and manages innovation to reality
What are the top 3-5 skills, experience or education required for this position:
1. Bachelor’s degree in a scientific field or associate degree with relevant experience
2. Preferred knowledge and/or relevant experience with Patient Reported Outcomes or outcomes research.