Raissa Zossou

Proven track record in managing clinical trial start-up procedures and regulatory requirements

• Preparing and submitting regulatory documents for IRBs/IECs and health authorities – EUCTR expertise

• Ensuring timely completion of study start-up activities, adhering to financial and quality standards.

• Collaborating with feasibility and site partnership managers for study feasibility and site selection.

• Monitoring and managing team workload to optimize resource utilization.

Ensure the launch and follow up of early access program

• Coordinated early access from launch to close out

• Wrote and submitted concept sheet of each EAP to local and global business decision

• Participated to the redaction of protocol of therapeutic uses (PUT) as required by health authorities

• Defined and managed project budget

• Discussed with the local and global supply chains to ensure the sourcing of required treatments

• Qualified, chosen and coordinated CROs in charge of early access follow up

• Managed the preparatory meetings and project launches

• Coordinated the preparation of efficacy and safety reports as requested by HA and HAS.

• Monitored closely CRO KPI

• Drafted work instructions and operating procedures necessary to monitor early access.

• Managed transversal team of 10+ including Market access, Regulatory affairs; Quality; Medical; Biometrics; PV; supply chain

Follow-up of international Phase II and III studies in Rheumatology and Transplantation

• Managed sites from selection to close out visits according to Novartis procedures

• Prepared audit; implemented and followed-up corrective actions

• Identified and managed issues – site and protocol deviations

• Planned site visits as required by monitoring plan

• Managed vendors involved in each protocol

• Collected essential documents, maintained investigator files and eTMF

• Identified with medical team of right sites to contact in case of additional sites

• Supported sites during recruitment periods.

• CRA lead to support project managers and other stakeholders on their activities: contract discussion within sites and direction; preparation of SIV SSV slides kits; support on relevant communications to sites.

• Mentored and trained new recruits according to Novartis internal procedures