Sadiqa Siddique MICR ACRP

Aligning with Saudi Arabia’s Vision 2030, Saudi Biotechnology Strategy 2040 & RDIA mission. Intelligent Solutions Discovery (ISD) is revolutionizing clinical research, biotech and healthcare scene in KSA through extensive clinical experience and power of Al. Providing strategic consultancy to international & regional clients. Capacity building and entrepreneurship initiatives for expediting the ecosystem development. Strategic soft landing for RDI.

• Human Investigation Program, lecturer and mentor for clinicians, dieticians, research nurses and staff. • Member KFSHRC Independent Review Boards (IRBs). • Initiated new solutions through feasibility and the analysis of available resources and gaps. • Developed and delivered effective GCP/ICH, patient safety and clinical ethics training courses and created all the content. • Advised the teams in local research hospitals around the conduct of clinical trials.

• Developed detailed clinical documents including trial protocols, SOPS, Manuals, Guidelines. • Independently monitored CRUK cancer first in concept (FIC) and first in man (FIM) Phase I (and sometimes Phase II) oncology trials across hospitals in UK. • As Phase I trials are heavily driven by pharmacokinetics and pharmacodynamics markers worked with Translational Scientists to ensure all data is captured accurately and highest quality. • Performed annual audits across several university hospitals, research labs, research pharmacies and diagnostic labs for patient safety, quality control (QC) and compliance. • Worked closely with the ethics committees and RECs, which safeguards the rights, safety and wellbeing of all trial subjects/patients. • Liaised and overseen various universities Clinical Research Compliance teams (CRCTs) to ensure clinical research projects and in particular clinical trials are conducted in line with any applicable regulations, international standards and university standards. • Worked directly with leading Clinicians, Professors and Oncologists around the globe in leading Cancer Centres to ensure smooth delivery of the innovative new cancer therapies/technologies. • Set up and managed the large clinical database reviews and interpretation of data by performing data analysis, statistical reporting. • Involved with scenario planning, modeling for finding the right solutions for healthcare sector. • As a team leader motivated site staff to ensure targets and timelines are met. • Identified the signs of suspected misconduct and performed root cause analysis and utilized available resources to implement corrective and preventive actions (CAPA) • Engaged in risk management with internal and external stakeholders. • Improved the quality of research by supporting and coaching the clinical teams to trial-specific, industry regulatory standards SOPs and Protocols. • CCRUK plain packs campaign, improving early diagnosis campaign.

• Project managed several Marketing Companies around the globe for day to day operations and conduct of the healthcare/drug development trials. • Authored Clinical documentation for clinical trial teams including protocols, amendments & administrative changes, consent forms, eCRF reviews, manuals and SOPs. • Being part of one of the first personalized medicine team IRESSA established partnerships to develop new diagnostic Biomarkers with Qaigen. • Managed several audits and inspections including FDA, MHRA GCP, GLP and GMP inspections for Quality Assurance and Quality Management Systems (QMS). • Project managed and overseen organization of various international events, conferences and investigator meetings for over 300 participants. • Managed the complex data reviews for Phase II & III oncology trials, closely worked with clinical Statisticians in interpreting the data and generate final report. • Created clinical research training material & delivered the trainings on GCP, Consent Process, Lab Manuals & sample handling, Discovery Medicine Booklets (for sample handling) for the investigator meetings, study specific training for monitors in different countries. • Demonstrated respect for cultural diversity and conventions while managing 10 marketing companies trial teams. • Global project planning and updating global research teams on project progress and other relevant issues. • Key stakeholders & partners: AstraZeneca Marketing Companies and University Hospitals NHS Trust Hospitals, Institute of Cancer Research, London, Cancer Research UK, Paterson Institute, Quintiles, ICON, Parexel, Qiagen

• Monitored and overseen the progress of various phase I and IIa Clinical studies. • Performed detailed data reviews and ensured quality control in accordance to the protocol and SOPs. • Generated SOPs for Good Clinical Practice (GCP) and the applicable Ethics and Regulatory requirements. • Trained the research staff on the conduct of the clinical trials and patient safety.