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Global Oncology PRO Manager (M/F/D)
Tasks:
Provide recommendation on Patient-Reported Outcomes (PRO) endpoints, instruments and assessment schedule based upon trial population, comparator and DS strategic objectives
Contribute to Patient Experience Data (PED)/PRO-specific aspects of protocol profile, clinical trial protocol and informed consent form development
Work with PRO implementation Lead to ensure PRO strategy is conducive to ePRO implementation capabilities
Review trial statistical analysis plans for PROs to ensure that proposed analyses match with PRO endpoints as per protocol
Review PRO-related TFL shells and actual results once finalized (PRO Team Lead to provide Senior Review)
Review PRO outcomes in clinical study reports (PRO Team Lead to provide Senior Review)
Respond to study team queries related to PED
Respond to PRO-specific questions received in Requests for Information (RFIs) as part of EU CTR submissions
Contribute to regulatory briefing documents as needed
Contribute to HTA interactions as needed
Consult the HEOR Asset Lead upon request of additional evidence generation to refine the selected PRO strategy for a given trial
Review externally-sponsored and real-world study protocols when PED are included
Perform the activities described above for ongoing studies and those starting until the end of the contract
Coordinate the performed activities with a junior PRO Team Member
Coordinate the performed activities with the HEOR Asset Lead or Delegate
Qualification:
Master’s or Bachelor’s degree in a relevant discipline (e.g., health economics, medicine, pharmacy, public health, epidemiology)
Minimum 5 years’ experience in the healthcare or pharmaceutical industry or consulting, working in the PRO field
Hands on experience with PRO methodologies and operations across all phases of the product life cycle is preferred
Track record of successful application of PROs with key external stakeholders such as FDA, EMA and relevant HTAs
Knowledge and experience of Oncology therapy areas is strongly preferred
Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including any aspects of drug development. Uses knowledge to the organization’s advantage; generates new ideas and enables the organization to improve business performance.
Demonstrates understanding and (advanced) knowledge of PRO methods and instruments, and the issues and challenges of applying these alongside clinical studies in drug development, and applies this knowledge to design PRO strategies
Ability to influence and navigate in a matrix organization, with proven ability to work cross-functionally, build coalitions and develop strong partnerships across functions
Demonstrates strategic thinking and ability to travel up to 20%
Outstanding writing and presentation skills and ability to work under pressure, to take accountability for business challenges, think strategically and tackle complex problems
Intellectual curiosity and ability to identify trends and emerging patterns in areas such as PROs, Patient Experience Data, HEOR
Requirements:
Start: 15.01.2025
Duration: 9 months
Capacity: 5 days per week
Location: 100% remote
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