Providing services to support clinical development including Project Management, CRO Supervision/Vendor Management, Clinical Monitoring and Medical Writing. See my position at Akela (below) for a description of each service. Ad hoc tasks welcomed.Contract positions held: Study Manager for small molecule drug discovery company; Clinical Operations Consultant to emerging pharmaceutical company; Technical Writer for blue-chip multinational; Senior CRA for global CRO; Medical Writer for event management CRO.

Role included all aspects of the CRO business from generating new contacts, to line management of contractors and hands-on delivery of projects. Projects for biopharmaceutical and medical device clients are categorised below, with recent examples: CRO Supervision – oversaw project teams from small, medium & large CROs for sponsors of pan- European & global trials of various indications, including phase II cancer & pain (2011). Reviewed study documentation, including monitoring reports & liaised with third party vendors. Acted as sponsor advocate but strove to support CRO project team, for example by managing sponsor expectations & expediting sponsor decision-making.Project Management – managed a number of full-service trials awarded to Akela. Included phase III rheumatology trial with participation in the sponsor’s NDA FDA inspection preparation, interviews & site training (2008). Accustomed to planning work, assigning & confirming ownership of tasks, documenting decisions & following-up to ensure timelines are met by cross-functional project teams & regularly summarising project status. Often performed dual role of PM & monitor.Monitoring – monitored trials in phases I to III in multiple therapeutic areas such as CNS, dermatology & infectious disease for drug & device studies. Work included site selection, trial initiation, IRAS application, close-down & audit. Prepared investigator sites for MHRA GCP inspection & was interviewed as site CRA (2006). Highly experienced & efficient; aimed for audit-readiness at all times, built good rapport with site teams & achieved low query rates.Medical Writing – edited numerous protocols; wrote minutes for the annual meeting of a high-level HIV collaboration committee (2006-2012); designed & validated a novel HIV questionnaire (involved liaison with a steering committee & focus groups) (2011); wrote & reviewed SOPs for multiple clients & Akela, & assisted in a major SOP integration project for a new global CRO (2008).

Ingenix (now trading as PharmaNet/i3) was a large CRO providing comprehensive clinical trial services. · Returned to Ingenix as temporary member of three-person team responsible for the proposal development of projects (domestic and global) for key clients.

· Member of five-person team responsible for all business development (BD) activities ex-US and for collaboration with US BD team for global studies · Managed eight client accounts in Europe and the US · Organised and co-ordinated proposal strategy meetings and core team meetings· Negotiated change order for US$2m with US client in record time.

· Developed ‘fit for purpose’ proposals and costs based on requests for proposal (RFPs) from pharmaceutical and biotechnology clients, involving cross-departmental liaison and production of high quality work, under extreme time pressure· Appointed as Acting Business Development Manager while BDM on leave.

· Responsible for UK site qualification, initiation and monitoring for phase I and III CNS trials· Coordinated cardiovascular opinion leaders for feasibility report · Prevented costly delay to depression trial by writing placebo defence letter that obtained UK ethical approval · Mentored new CRAs and co-monitored at 60 patient site in France to meet deadline for interim database lock.

UCTi was a central laboratory service provider and had laboratories in London and New York, and a strategic alliance with Melbourne Pathology.· Accountability for all Phase I work from RFP and quotation, initiation and project management through laboratory· Achieved high client satisfaction levels by meeting demands for tight turnaround times, often in delicate situations, under constant time pressure· Organised and presented at open day for current and potential Phase I clients.

· Provided Senior Project Managers with support in every aspect of laboratory provision for multinational phase II and III studies.