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Patient Reported Outcomes Manager I
Mindlance
🇺🇸 United States
Hybrid
Manager or above
2 days ago
- Vault
- GCP
2 days ago
Not enough detail in this posting to match
1. COA licensing and translation experience
2. 6+ years of clinical research, outcomes research, or project management experience
3. Strong project management and organizational skills
4. Experience collaborating with cross-functional teams and external stakeholders
5. Bachelor’s degree in a scientific, healthcare, or related field
Purpose:
The Patient Reported Outcomes Manager reports to a CDIT (COA and Digital Implementation Team) Navigator 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 Study Start-Up organization.
Responsibilities:
•Responsible for 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 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 with company; 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 and technical expertise and training to the CPD organization in support of PRO/ePRO activities during study start up. Provides direct supervision to PRO management associate(s) creating an inclusive and innovative environment
Qualifications:
•Bachelor's Degree in a scientific field or equivalent with relevant experience is acceptable A minimum of 1 to 3 years of global (direct or peripheral) clinical research or project management experience.
• Must have knowledge and minimum 1 to 3 year hands on and relevant experience with Patient Reported Outcomes or outcomes research.
•Demonstrates a high level of core and technical competencies through management of various components of the PRO/ePRO process. Possesses good communication skills and demonstrated leadership abilities
• 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
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
Patient Reported Outcomes Manager I · Mindlance