Médecin Développement Clinique

Poste en télétravail complet.

• 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:

o Steering Committee: contact with selected members, Set-up, Charter development, meetings, reporting and documentation.

o Data Monitoring Committee (DMC): contact with selected members, Set-up, Charter development, meetings, reporting and documentation.

o Adjudication Committee: contact with selected members, Set-up, Charter development, meetings, reporting and documentation.

• Medical support and guidance to (and training of) sanofi 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

• Working language and document writing in English