Business lead for intelligent study design and informatics platform to transform study planning and feasibility processes

Line Management for UK SCP TeamLead of Early Planning PodClinical Project Manager & Clinical Trial Intelligence Analyst for Project and Study Planning

Operational lead for electronic health records (EHR) ancillary study to evaluate suitability of EHR in the identification of study participants and tracking of progress throughout the trial.Regional leadership of European countries participating in large cardiovascular outcomes trial of GLP-1 T2DM medication.

Business Lead for StudyOptimizer recruitment planning tool (IMS Health). Activities included: Business process mapping for patient recruitment planning activities; Change management oversight and implementation; System integration and data flow mapping; Development and delivery of global training programme for study managment users;Senior stakeholder management across therapeutic areas;Chair of StudyOptimizer Roche champions global networkSupport therapeutic area teams, programme and study level teams in the development and implementation of patient and investigator recruitment and retention strategies.

Local Study Management Team and Clinical Operation Lead for phase IIIb study in Adult Rheumatoid Arthritis umbrella programme.Study and Site FeasibilityStudy Management LeadershipVendor Evaluation and SelectionStudy Start-up Activities in UK environment (CCRN, CSP, IRAS)CRA Team Leadership, TA Training and Study Oversight

Current Project:Global Studies Manager for two pediatric studies evaluating a new formulation of a treatment of different forms of juvenile idopathic arthritis (JIA). Activities include protocol review and feasibility; internal global operations lead; vendor assessment and selection.Previous Projects:Clinical operations lead for a variety of study deliverables in a global outsourced Phase III dyslipidemia programme (CETP Inhibitor). These responsibilities include:• Global operation lead for start-up and recruitment activities in a post-ACS study that achieved it’s recruitment objectives 6 months ahead of plan• Regional Sponsor Lead for North and South American Countries in CV Outcomes Megatrial (700 sites, 20,000 patients)• Global lead for patient recruitment and retention activities for both traditional print and innovative digital media (incorporating digital informed consent process and iPad app development). Global team incorporated representatives across the CRO, ARO and Digital Service Provider partnership• Sponsor management responsibility of Clinical Research Organisation (CRO) teams, Academic Research Organisation (ARO) and Service Providers (IVRS, Patient Recruitment & Retention Agencies, Central Laboratories, Event Management Agencies)• Lead for the concept, planning and execution of a global programme of investigator meetings for a CV Outcomes Megatrial

Held roles of increasing responsibility within the Cardiovascular & Metabolic Global Clinical Operations function.Responsibilities have required team leadership of both project and study management teams as well as cross-functionional working groups in areas such as study conduct, drug supplies and distribution; regulatory and ethics committee submissions; electronic case report form (eCRF) design; performance benchmarking and metrics analysis; management of ARO & CRO activities across a number of different projects; and management of transnational study teams (up to 22 countries).Project compound classes worked on include: Thiazolidinediones (TZD), Di-Peptidyl Peptidase IV (DPP-IV) Inhibitor and Sodium Glucose Transporter 2 (SGLT-2) Inhibitor.Previous roles: Senior Study Manager & Lead Study Manager

Primary role involved with the design, conduct and monitoring Clinical Pharmacology studies utlising PET/MRI imaging. Responsible for study teams contributions to the development and design of a concept protocol, regulatory compliant full protocol and final study report or manuscript. Responsible for the coordination of scientific and technical contribution of all relevant disciplines to ensure study conducted in accordance with company policies, GCP within agreed timelines and budgetResponsible for the effective management of a study in the clinical phase and coordination of activities.

Co-project managed a key pivotal study assessing the treatment of anaemia in patients congestive heart failure programme. This role required:• Involvement within the European Clinical Study Management Team• Input on study design and execution• Authorship of study monitoring plans and core laboratory manuals (Cardiovascular Magnetic Resonance and Cardiopulmonary Exercise Testing)• Development of a patient referral network within and surrounding West London into hub centreOther responsibilities included:• Evaluation and management of all UK centres participating in phase II studies in the congestive heart failure programme• Collaboration and co-ordination of a CRO in the initiation of a phase II study with a novel design • Negotiation, execution and tracking of investigator site contracts and budgetsPrevious study activities included the initiation, monitoring and completion of Phase II-IIIb trials in Nephrology and Oncology Therapeutic Areas