General Responsibilities/Tasks:
- Document writing: abbreviated protocol, protocol, informed consent (ICF), protocol and ICF amendments related to the assigned complex / pivotal clinical trials in the field of clinical development in immunology and Inflammation.
- Medical support for real world data pressure test and for operational feasibility.
- Contribution to answers to HAs, ECs, clinical sites and study team (global and locals).
- Participation and preparation to various meetings (investigators, monitors, etc.).
- Contribution to management of committees:
Steering Committee: contact with selected members, Set-up, Charter development, meetings, reporting and documentation.
Data Monitoring Committee (DMC): contact with selected members, Set-up, Charter development, meetings, reporting and documentation.
Adjudication Committee: contact with selected members, Set-up, Charter development, meetings, reporting and documentation.
- Medical support and guidance to (and training of) team (CSO PL, GSM, biostatistician, Medical Advisors, CPLs/etc…), CRO and investigators.
- Medical input on study plans (CMP, MRP, SS review and SRMP), CRF, CRF completion instructions, deviation list and management.
- Medical support and guidance to data review, statistical surveillance, coding, medical validation and Clinical case review material development.
- Clinical Case review (patient profiles) review and validation of narratives.
- Statistical Analysis Plan review and endorsement.
- Contribution to Key Result Preparation.
- Clinical Study Report development (drafting of specific sections, review).
- Preparation in anticipation and answers to Audits and inspections.
- Review of draft publications,(Support to publications).
- Preparation of audits and inspections.
- Support to submission.
- Support to clinical development plan.
