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Clinical Outcome Assessment (COA) Lead

Direkt bewerben
Temporär
Kategorie
1 Jahr
Dauer
Basel
Arbeitsort
100%
Pensum
For our client, an internationally operating pharmaceutical and life sciences company, we are seeking an experienced Clinical Outcome Assessment (COA) Lead for a permanent position. In this strategic role, you will drive the development and execution of global COA strategies across clinical development programs and therapeutic areas.
Deine Skills
  • You hold a Master's degree in Life Sciences, Psychology, Sociology, Psychometrics, Pharmacy, Biostatistics, or a related discipline. A PhD is considered an advantage.
  • You bring several years of experience in Health Outcomes Research and possess deep expertise in COA/PRO methodologies, instrument validation, psychometrics, and global regulatory requirements.
  • You have strong analytical skills and can critically evaluate, interpret, and validate qualitative and quantitative COA data to generate regulatory-ready evidence.
  • You have a proven track record of developing and implementing strategic COA frameworks that support both regulatory submissions and market access objectives on a global scale.
  • You demonstrate strong leadership in cross-functional and matrix environments, effectively managing internal stakeholders and external vendors while driving results through collaboration.
  • You are familiar with electronic COA solutions, digital data collection standards, and industry best practices, and you bring a proactive, accountable, and solution-oriented mindset.
Deine Aufgaben
  • You lead the development, implementation, and continuous enhancement of global COA strategies, ensuring alignment with regulatory, reimbursement, and evidence-generation requirements.
  • You advise clinical development teams on the selection of appropriate outcome assessments and take ownership of COA-related content within protocols, statistical analysis plans, clinical reports, and other key study documents.
  • You oversee COA projects throughout their entire lifecycle, coordinating internal functions and external service providers involved in validation activities, translations, cultural adaptations, and eCOA implementation.
  • You are accountable for content validity, psychometric validation, and score interpretation activities, ensuring that evidence meets predefined standards for regulatory labeling claims and health technology assessment submissions.
  • You collaborate closely with Clinical Development, Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, and Market Access teams to analyse, interpret, and communicate COA outcomes in regulatory and scientific deliverables.
  • You support interactions with health authorities and scientific communities, contribute to dossiers, publications, and briefing documents, and continuously integrate emerging COA methodologies and industry best practices into development programs.

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