Ensuring that all team members were trained appropriately to perform their tasks, oversaw numerous clinical trials with over 100 participants,hired,trained,and assisted staff where needed to carry out the many tasks involved in Phase I-4 trials. I assurance and quality control checks on all charts and source documents daily as well contributes to the planning, tracking, and closure of clinical studies also monitors and reports on clinical study budgets and timelines aslo engage with clinical and business leadership to report on study status and, when necessary, presents scenarios for maintaining on-time and on-budget study progress,

Coordinate Clinical Trials, visit trial sites regularly. Acts as liaison between project manager and research-site personnel. prepare final reports and occasionally manuscripts for publication. identify/select an investigator who will be responsible for conducting the trial at the trial site, set up the trial sites - ensuring each site has the trial materials, including (IMP), train the site staff to trial-specific industry standards, monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis verify that data entered on to the CRFs is consistent with patient source documents for (SDV) verification.

Maintain contract with the sites and remotely monitor compliance issues on an ongoing basis,. Perform site visit from selection to closeout, long term management of site via interim ,monitoring visits Assisted in the design and oversight of project monitoring services including training site patient recruitment, site/document management, monitoring project site budgets and regulatory filings that align with SOP’s study guidelines and GCP best practices as well, compliance with overall study timelines to maintain recruitment progress, data cleaning and appropriate IMP management, and provide, evaluate and ensure patient , data quality and scientific integrity of clinical trials.

Managed and maintained accurate data records for all clinical trials and research studies, ensured all participants provided informed consent before their involvement in any research activities, adhered to strict protocols outlined for each clinical trial to maintain integrity and accuracy of data, performed routine clinical monitoring to track patient progress and identify any adverse reactions, demonstrated strict adherence to regulatory guidelines and standards throughout all clinical research activities.

*Coordinated and implemented the feasibility, set –up, budgeting, initiation, supervision of monitoring and closure of PHASE II-III clinical trials, provided support for the medical review of SAE cases, provided medical feedback and opinion for protocol, ICH, HIPPA development via the Clinical Study Directors and International Trial Managers as well constructing and controlling the trial budget at local level, conforming and leading the local Study Team.

*Travel to Oncology sites, management of 4 CRAs and 1 CPA to perform all study related activities from feasibility to study closure, responsible for the definition of the development program at local level for phase IIb and life cycle management for Hemato-oncological, contributed to the generation of clinical protocols, development plans and the evaluation of unexpected AEs SAEs, prepare regulatory documents for Sponsor/CRO, investigator agreement, financial disclosure, curriculum vitae, IRB/IEC membership, lab-related documents, delegation of authority, site signature log, prepare for and respond to internal and Sponsor/CRO audits, regulatory inspection, & obtain study summary and close-out letter for IRB/IEC/Sponsor/CRO .