Leading a team of 50+ CRAs and Project Managers in South Asian region, managing several Phase 2, 3, 4 and Bioavailability studies in different therapeutic areas.

Setting-up (Real World Evidence) RWE local processes and to establish Clinical Trials capability in Pakistan.

Responsibilities and Achievements:Leading a team of auditors conducting Investigator Site Audit (ISA), Process Audits (PA), Vendor Audits (VA) and supporting Client Audits (CA) and Regulatory Inspections (RI). Developing Audit Plans, tracking progress and performance, and reviewing findings and reports as well as keeping key stakeholders up to date on recent developments.

Responsibilities and Achievements:Only medical person in the company thus keeping oversight on all clinical trials in all therapeutic areas and regionsDeveloped expertise in new therapeutic areas e.g., gene therapy, stem-cell therapy and ultra-rare diseases In QA role, conducted internal and external audits, customer complaint and non-conformance investigations and supporting and facilitating inspections

Responsibilities and Achievements:Development of Quality Management System (QMS)Setting-up of new company, including development of policies, procedures and processesHiring and training of the teamBusiness development

Managing Quality and Training in Asia-Pacific, Middle East, Africa and Central Asian. Developed and led Quality and Training Network across 15 countries. Conducted internal reviews, developed and implemented Quality Plans and CAPAs, supported implementation of Risk Based Monitoring and facilitated inspections.Responsibilities and Achievements: Simultaneously led 4 different successful teams of 37 individuals in total Primary point of contact for all regional Quality & Training needs Organized and led EMAP Quality and Training Network Facilitated introduction of new processes, technologies and systems across EMAP Led 15 projects from Feasibility to Completion Worked on Phase I – IV clinical trials in Oncology, Respiratory, Dermatology, Urology, Infectious Diseases, Immunology and Cardiovascular (including investigator-initiated studies, epidemiological and non-interventional studies) Smooth transition of several projects to Novartis as part of GSK-Novartis deal Transition of several projects to PPD as part of outsourcing agreement

Key Achievements:Led a team of 17 individuals managing 50+ clinical trials from Phase II to IV in all therapy areas i.e. Oncology, CVS, Dermatology, Infectious Diseases, Endocrine, Neurosciences, Urology, Immunology, Gastrointestinal, Psychiatry and Paediatrics as well as Epidemiology studiesRedesigned team processes and procedures to streamline conduct of clinical trials to further enhance data quality with focus on patient safety. Team was recognized as best performing team globallyDeveloped trusting relationship with Regulatory Authorities to help them frame National Regulations including offer of advice on various issues to provide potential solutions

Additional Roles: Regional Metrics Advocate for Middle-East & North Africa (MENA) Medical Monitor for large cardiovascular study Clinical Research Training and Quality AssuranceResponsibilities and Achievements: Led a team of 12 individuals managing 50+ projects from Phase II to IV in all therapy areas Best Clinical Research Manager award in 2008 and 2009 Among the top ten recruiting countries globally with quality data. The team was recognized as the best in GSK Clinical Research (2009 Global Metrics) My performance as Medical Monitor was recognized by GSK R&D Leadership

Key Achievement: Managed and monitored 27 Phase II – IV clinical studies in different therapy areas

Coordinated 5 Phase II – III clinical studies in an Oncology hospital and research center

Responsible for patient care in outpatient, inpatient and emergency units