Amadou Diakite

Managed 6+ Vendors and outsourcing of 3+ projects, supporting business development in outsourcing. Monitored clinical partners involved in the outsourcing processes in coordination with the business units. Create and update 3+ project-specific Request for Proposal (RFP) and Statement of Work (SOW) documents. Supported PSO/FSO projects, ensuring timely completion and efficient, high-quality project delivery.

Led 6+ global tirals (Phase I-III) in Oncology, Hematology and Neurology, negociated 40+ budgets (CROs/sites/vendors), and

finalized contracts and study timelines.

Collaborated with cross-functional teams to developped/reviewed 6+ protocols, monitoring plans, deviation plans, safety

plans, and data management plans,

Achieved 99% enrollment targets and ensured GCP/regulatory compliance (Zero major findings in audit).

Tracked trial progress, reporting to senior management with 99% on-time updates.

Mentored 20+ CRAs/CTAs/Local CPMs and collaborated with QA, PV and data management teams.

Ensured adherense to local/international regulations, achieving 98% completeness in audits.

Prepared and submited trials documents to FDA, EMA, ANSM and CPP for 3+ trials.

Oversaw TMF compliance (99% completeness) ahead of regulatoy inspections.

Implemented eCRFs in 3+ global trials, ensuring data accuracy and integrity.

Managed relationships with 5+ CROs, 50+ investigators and external partners (central lab, IWRS ...).

Managed the selected vendors, led the review and finalization of contracts and ensured close follow-up of study timelines and

budget compliance.

Supervised 10+ CRAs, reviewed 100+ monitoring reports, and reducing discrepancies by 99% through targeted training.

Identified risks at 7+ sites, reducing protocol deviation by 98% via mitigation strategies.

Served as the primary contact for 50+ investigators, CROs, and vendors, provided weekly project updates.

Ensured data integrity accross 3+ global trials, coordinating 9+ audits with a 98% success rate in adressing findings.

Trained 20+ CRAs/CTAs/site sta on protocols, GCP , and monitoring procedures, provide ongoing support and mentorship to

monitoring teams reducing discrepancies

Trained 5+ CRAs/CTAs and 20+ site staff, reducing protocol deviations by 99%, Ensured data integrity in 3+ global trials through robust monitoring plans. Conducted 50+ co-monitoring visits, achieving 99% eCRF and TMF completeness. Improved site compliance by 98% through effective issue resolution.

Maintained 100% inspection-ready TMFs.

Tracked KPIs, boosting CRAs/CTAs performance by 30%.