Extensive global study management experience gained from over 15 years working for pharmaceutical companies and CRO’s, across therapy areas (Oncology, CNS, Inflammation) and phases (I-III). Proven leadership in study start up, maintenance and close out working to ICH GCP. Quality and performance management of CRO’s and vendors. Timeline management and oversight of key study deliverables on pivotal trials. Strong leadership, relationship building, motivational and communication skills.

Clinical Research Study Lead Early Development (freelance) @ Currently leading cross functional teams in a phase II CNS study and phase Ib dose expansion Oncology (immunotherapy) global trial. Experience in managing in-house high priority phase 1b first in patient study (adult and paediatric population) in rare diseases. From July 2014 to Present (1 year 6 months) Clinical Project Manager phase III (freelance) @ Global study management (helping manage Asian and European component of phase III pivotal epilepsey trial). Coordination and supervision of all on-going aspects of a clinical study. Vendor set up and on-going quality and performance management (CRO, Central Lab, IVRS/IWRS, recruitment vendor) Strong working knowledge of ICH-GCP. Developed clinical trial documentation including protocols, informed consent forms, site feasibility questionnaires, monitoring plans etc. Reviewed an approved ethics and regulatory submission documentation. Planned and presented at large investigator meetings, coordinator meetings and CRA training days. Performed investigator site motivational visits and extensive co-monitoring visits. From February 2010 to December 2013 (3 years 11 months) Cologne Area, GermanyClinical Study Manager- Early Development (Freelance) @ Planning, management and reporting of phase I clinical trials (CNS). Assessed vendor bid proposals for vendor / CRO selection. Managed phase I units performance, metrics and delivery to timelines. Led study kick off meetings, coached and mentored in-house CRAs and co-monitored sites. Managed invoices and vendor budgets. Led CRO lessons learnt meetings. Ensured audit inspection readiness. Trouble shooting site issues. From May 2007 to December 2008 (1 year 8 months) London, United KingdomClinical Study Operations Manager @ Global Study Operations Manager phase II (Permanent). Responsible for global proof of concept studies (phase II Rheumatoid Arthritis) using electronic data capture. Developed operational plan and managed operational implementation of trial (drug / site supplies, study invoices, rolled out eCRF tools to sites, on-going review of performance metrics / targets etc). Led investigator meetings and CRA training. Coached and mentored colleagues evaluating their performance. Extensive site Monitoring and site initiation visits. From June 2000 to May 2007 (7 years) Clinical Data Manager @ From November 1998 to May 2000 (1 year 7 months) London, United KingdomClinical Data Manager @ From December 1996 to November 1998 (2 years)

Master of Science (MSc) @ Kings College London From 1995 to 1996 BSc Biochemistry and Physiology @ University of Southampton Gus Gata-Aura is skilled in: Clinical Research, Clinical Development, CRO, GCP, CTMS, EDC, ICH-GCP, Drug Development, Clinical Monitoring, Regulatory Submissions, Pharmaceutical Industry, Therapeutic Areas, Clinical Trials, Phase I, Clinical Data Management, Clinical Study Design