Michael Foran Email & Phone Number

Glasgow, Scotland, United Kingdom

Connecting People with Technology: Expertise in InnovationAdvance life-changing treatments by using our expertise to navigate a rapidly changing technological and regulatory environment. Use digital and healthcare innovations to augment efficacious study design, decrease site, patient and caregiver burden and increase diversity, recruitment and retention whilst maintaining high quality data and protecting endpoints.

Partnering with clinical delivery teams to enable implementation and refinement of Decentralized Clinical Trials delivery process.

Greater Glasgow Area

Glasgow, Scotland, United Kingdom

Operational Transformation & Performance: Ensuring and improving delivery of Feasibility / Site Identification and Site Activation through oversight, business process optimization and development, deployment & adoption of new software systems. - Drive adoption of change directly and by establishing & leveraging business support networks, setting adoption / compliance targets and driving delivery.- Project Manage process optimization initiatives to improve and accelerate Feasibility/Site Identification and Selection and Regulatory Start Up focusing on people, process and technology.- Focus on Regulatory Start Up process cycle times and ways to reduce them- Product owner for new Feasibility/Site ID software tool during elaboration, construction, transition/adoption. Responsible for inputting into elaboration and construction. Owner for transition and adoption. Key activities included evaluating product for go/no go; elaboration and prioritization of enhancements including obtaining business input/alignment and understanding cost impact/time saving of system enhancements; UAT oversight; input into design user support & access models including requirements for turn around times and plan to monitor ; early adopter plan; design and implement Business Support Network; stakeholder communication.- Business deployment and adoption lead for RSU software tool during elaboration, construction, transition and maintenance. Owner for adoption. Key activities included input into elaboration and prioritization of enhancements; trending of user support issues, monitoring timeliness of resolution & actions to remediate; interacting with other product owners (e.g. CTMS, eTMF) to address integration solutions and issues; driving adoption through leading Business Support Network leveraging training, adoption metrics and communication.

• Oversight of Feasibility/Site ID, Regulatory & Start Up activities to ensure on time quality delivery• Line Management of Regulatory & Start-Up Leads including onboarding, training, mentoring and oversight to ensure on time quality delivery• Analysis of RFPs to give strategic input into Feasibility/Site ID, Regulatory & Start Up aspects of proposals as part of business development activities• Customer Account support including delivery oversight and initiatives to improve and accelerate Feasibility/Site Identification/Selection and Regulatory Start Up• Change management, and supporting implementation of global initiatives• Line Manager mentoring• Resource management to ensure the right resource on the right study at the right time

• Oversee the execution of Start Up for Global protocols and program’s in accordance with agreed Regulatory Start-Up (RSU) strategy.• Manage direct reports (Global RSU Leads) based in Europe and their delivery.• Standardize RSU processes• Implementing department initiatives to ensure on time delivery of our clients clinical programs.

Global Regulatory Team Lead (gRTL) for multi-centre, multi-national clinical trials throughout the EU, the rest of Europe, Asia, Latin America and South Africa.Giving regulatory affairs consulting, strategic and operational support for business development activities.Mentoring and development of junior staff within the regulatory affairs global business unit.Preparation of technical regulatory documentation including Investigator Brochures, Investigational Medicinal Product Dossiers.Contribution to bespoke Quintlies regulatory affairs database.Standard Operating Procedure Task Force Leader.Member of process improvement task force.

Global Regulatory Team Lead (gRTL) for multi-centre, multi-national clinical trials throughout the EU, the rest of Europe, Asia, Latin America and South Africa.Giving regulatory affairs consulting, strategic and operational support for business development activities.Mentoring and development of junior staff within the regulatory affairs department.Preparation of technical regulatory documentation including Investigator Brochures, Investigational Medicinal Product Dossiers.Contribution to bespoke regulatory affairs database.Standard Operating Procedure Task Force Leader.

Global Regulatory Team Lead (gRTL) for multi-centre, multi-national clinical trials throughout the EU, the rest of Europe, Asia, Latin America and South Africa.Giving regulatory affairs consulting, strategic and operational support for business development activities.Preparation of technical regulatory documentation including Investigator Brochures, Investigational Medicinal Product Dossiers.Contribution to bespoke regulatory affairs database.

United Kingdom

Multiple roles including: Regulatory Affairs Secondment. Technical Lead - Analysis Group ELISA technical lead, GMO detection methods for biotech product registration with EU, molecular characterization for internal customers.Project Coordinator - Point of contact for all local issues on this biotech project. Responsible for ensuring all efficacy trials, in-vitro, expression and molecular data were produced and collated for trial applications. Also organised germplasm movement between USA, UK and China, interacting with relevant authorities as required.Molecular Biologist – Expression and Molecular Analysis: Optimization and on-time execution of gene expression and molecular analyses, and evaluation of in-vivo efficacy of transgenics, ensuring rapid project progress.Cell Biologist – Transformation: Initiation and maintenance of expression systems using embryogenic cell suspensions.