Value Evidence Analyst - Senior
AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Switzerland, Germany and Czech Republic.
We are currently looking for a Value Evidence Analyst Senior to plan the evidence generation to support the value of the vaccines in Research and Early Development, contributing in the generation of cross functional Value Evidences Plans. The activities include (but are not limited to):
- Lead the implementation of PRO (Patient Reported Outcomes) / clinical outcomes assessment (COA) strategies for assets in research and development. Potentially lead PRO studies
- Developing first high level PRO strategy including conducting a literature review
- Support the appropiate implementation of PROs in clinical trials, including writing relevant portions of the clinical trial protocols, training investigative site personnel on PRO principles and appropriate administration of PROs in the clinical trials
- Collaborate with clinical and statistical teams to ensure that COAs are appropriate analyzed and described in statistical analysis plans, study reports and publications
- Under direction of PRO Manager, support relevant sections of documentation and communication and questions for regulatory agency meetings, support in meetings with regulatory agencies.
- Prepare abstracts and manuscripts presenting PRO results from clinical and PRO development and validation studies, aligned with publication strategy With PRO team, develop and provide training on COA-related topics to other departments, as needed
- BA / MA degree Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research or similar
- Experience in pharmaceuticals, particularly in drug development, so as to understand drug development process, with demonstrated experience in clinical trial planning and execution
- Experienced with PRO/COA requirements for regulatory and HTA/reimbursement agencies including understanding of the FDA Patient Reported Outcomes Guidance
- Experience with managing PRO development and validation projects
- Strong communication skills, with stakeholder engagement with Clinical, Health outcomes and Regulatory