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Senior HEOR Manager Patient-Reported Outcome (12 months contract) m/f/d
As a Senior HEOR Manager COAs/PROs, you are at the forefront of clinical outcome assessment (COA) activities and projects across various therapeutic areas within our organization, always prioritizing a 'patient-first' mindset. Your role is pivotal in COA strategic planning and execution, ensuring high impact and scientific integrity. You will collaborate and lead internal cross-functional teams and external vendors to successfully implement COA initiatives, including patient-reported outcomes (PROs), clinician-reported outcomes (ClinROs), and other COA assessments for clinical programs. Your mission is to enhance the patient experience from trial design to final reporting, ensuring commercial and regulatory success of products that include COAs in their endpoint measurement strategy across clinical lifecycles.
YOUR TASKS AND RESPONSIBILITIES:
- Lead the development and execution of strategic COA plans for products across therapeutic areas, owning the COA Strategy Document for each program;
- Guide internal teams in selecting appropriate COAs for clinical trials and provide input into clinical documents throughout the trial lifecycle;
- Lead the scientific execution of COA projects with external vendors and internal stakeholders;
- Provide guidance to project teams, ensuring adherence to COA regulatory requirements and best practices;
- Oversee COA validation and interpretation, ensuring psychometric evidence meets regulatory and HTA criteria;
- Collaborate on COA data analysis and reporting, preparing regulatory or scientific documents as needed;
- Prepare COA-related regulatory and scientific submissions, leading relevant sections for regulatory agencies;
- Stay current with COA-related scientific organizations and methodologies, incorporating advances into programs.
WHO YOU ARE:
- At least a master's degree in Life Sciences, Psychology, Sociology, Psychometrics, Pharmacy, Biostatistics, or a related field. A Ph.D. is preferred;
- 5+ years of applied experience in health outcomes research, with demonstrated leadership and expertise in COA/PRO methodology and regulatory requirements;
- Strong ability to analyze and validate COA data, apply COA validation methodologies, and derive regulatory-ready insights;
- Ability to develop strategies and implement tactics for optimal clinical outcome strategy addressing market access or regulatory needs globally;
- Excellent leadership skills with experience leading cross-functional teams and managing external vendors;
- Understanding of electronic COA migrations and latest eCOA implementation standards;
- Proven ability to interact effectively with internal and external stakeholders, navigating competing priorities;
- High degree of empathy and inclusive mindset to work with diverse external stakeholder groups.