Michael Howarth Email & Phone Number

United Kingdom

Manage global medical device studies (ortho, wound management) from start-up activities, live phase, through to study closeout.Utilise clinical systems (CTMS, eTMF, EDC), ensuring trial milestones are achieved to the expected quality and compliance.Manage cross-functional study teams as well as providing oversight to contracted vendors and CROs, ensuring KPIs are met and and study procedures are followed.Identify, assess and select clinical trial sites and coordinate appropriate monitoring of study live phases, as well as initiate and develop essential documents such as monitoring plans, study protocols, CRFs, study reports.Support budgetary tasks such as cost estimations for proposed trials, tracking of project spends and managing trials against budget.Work closely with internal stakeholders including Clinical Strategy, R&D, and Commercial teams to achieve project and franchise goals.

United Kingdom

Manchester Area, United Kingdom

Lead Data Manager on an Early Phase study, as well as assisting on a number of ongoing Phase I-III clinical trials across a range of therapeutic areas and subject populations.Prepare and review DM trial documentation such as Data Management Plan, Database and Edit Check Specifications, CRF completion guidelines, as well as performing verification and User Acceptance Testing on configured databases.Perform data cleaning activities, query management, reconciliation of external data (e.g. SAE, lab results etc.) and SAS listings review.Attend and present in meetings with the wider Data Management team, Medical Monitoring and trial Sponsor teams, reporting on trial progress and highlighting any ongoing issues.Experienced user of a number of EDC (RAVE Medidata, IBM Clinical Development, ClinSpark) and eTMF (Trial Interactive) systems.Ongoing maintenance of DM trial documentation in the eTMF

Alderley Park

Startup Biotech company researching unique RNA/cfDNA biomarker expression signatures in biofluids with the goal to develop a commercial early stage lung cancer diagnostic assay.Clinical database management: built and managed clinical trial data and sample bank Excel databases, ensuring GCP and GLP compliance.Perform clinical data quality control: review, clean-up, report/resolve data discrepancies as appropriate, implemented protocols for correct data entry.Coordinate transfer of all study related data to internal and external biostatisticians for analysis.Perform clinical data/sample bank analysis and generate regular reports; presenting and discussing findings at global meetings with wider team and company stakeholders.Assisting in LIMS setup and implementation: relational database, focused on clinical data input, sample search/withdrawal workflows, involved some basic SQL querying and dashboard creation.Project lead for ‘saliva exosomal RNA’ pipeline: design/perform experiments, data analysis, create and develop processing workflows, write and manage SOPs, train team members.

Oxford, United Kingdom

Central role in coordinating transfer of live human cortical samples for electrophysiology recording and further histochemical processing.Responsible for all project-related administrative duties and ensuring compliance with Human Tissue Act (HTA) and Good Clinical Practice (GCP) codes of practiceImplemented a database able to track human samples through their entire research life cycle; from receipt, storage, processing through to disposal.Created and managed documents such as SOPs, MTAs and all Health & Safety-related documentation.Expertise in designing, performing and interpreting immunohistochemical/fluorescence experiments.Experienced with a range of microscopy techniques including brightfield, epifluorescence and confocal, as well as various image analysis and editing software.Regularly present research findings in lab meeting and scientific reports and have contributed significantly to scientific papers, posters and grant applications.Heavily involved in general lab management including maintaining and monitoring lab equipment and supplies, clerical duties, training of junior staff and students.

Oxford, United Kingdom

Perform EEGs for both paediatric and adult neurophysiology services as well as emergency EEGs on wards and Intensive Care Units.Analyse EEG recordings, write factual technical reports, liaise with clinicians, discuss results and assist in diagnoses.Assist in neurophysiology-related clinical research in-line with GCP guidelines.

Manchester, United Kingdom

Assist in vivo electrophysiological recordings and immunohistological processing of tissue.General lab maintenance and administrative duties, as well as training of new students and staff