Adam Walker

Adam brings a wealth of global experience gained from key biometrics and clinical data management leadership roles across major pharmaceutical companies, CROs and regulatory agencies. He is a trusted advisor to clinical technology companies — including EDC and eClinical platform providers — on product strategy, validation, quality management and regulatory compliance, with a proven track record in real-world data, evidence generation and CDISC-based clinical data standards. This positions him as the ideal consulting partner for organisations building the next generation of AI-enabled clinical data science platforms.

Passionate about AI, e-Health and Real-World Evidence, advising platform vendors (Castor EDC, Clindox, Docuply) on product roadmaps, functionality, validation and compliance. Highly quality- and detail-focused Biometrics professional with experience across all phases of the clinical trial process in a career spanning nearly 30 years, including Orphan Drugs. Degree in Pharmaceutical Sciences; pioneered implementation of EDC and paper-based CDM tools (Medrio, Oracle Clinical, Inform) alongside Quality Management systems, with strong working knowledge of CDISC standards (SDTM, ADaM) and clinical metadata.

Thorough knowledge of ICH-GCP and 21 CFR Part 11, with active thought leadership on AI governance in clinical research — the EU AI Act, EMA Draft Annex 22 and FDA/EMA guiding principles for AI in drug development. Cross-sector exposure across CROs, Pharma and Government Agencies — including a technical Pharmacovigilance transformation programme for the MHRA — giving a real understanding of future requirements for data, analytics, AI and their integration.

Consultant — Director, Technology Enablement at Jazz Pharmaceuticals (2025-08 – 2026-03)

Business Implementation Lead supporting technology enablement activities across the organisation.

Founder & Host at Pharma Prescribed Podcast (2025-05 – Present)

Long-form video and audio show where leaders, innovators and hidden voices in healthcare open up; bi-monthly publishing across YouTube and podcast channels, with a sustained focus on AI governance in clinical research.

Scientific Advisory Board Member at Docuply (2025-01 – Present)

Advising on development of an eTMF and archiving quality system, with oversight of end-user experience and regulatory compliance.

Consultant at Stridon Clinical (2025-01 – Present)

Protocol review and compliance against regulatory standards; quality assurance to identify inconsistencies, errors and gaps; detailed QC reporting and audit-ready record keeping.

Medical Evaluation Data Management Lead Consultant at AstraZeneca, UK (2021-01 – 2024-12)

Reporting and vendor management for real-world evidence and observational studies in the Vaccines & Immune Therapies unit. Oversight of vendors and CROs to ensure alignment with quality and process excellence.

Consultant at Prime Global, UK (2020-11 – 2021-02)

Advised on a minimum viable product from a requirements-gathering exercise to support a fully integrated technology platform; selected and introduced technology partners and delivered commercialisation options to the Executive Team.

Consultant at Castor, NL (2020-05 – 2021-05)

Advised on and implemented development of the Castor EDC platform and associated functionality; supported the technology roadmap and QMS documentation with consideration for Big Data, Machine Learning and AI; delivered a full capability audit with forward recommendations.

Consultant at Clindox, UK (2020-05 – 2020-05)

Advised on and implemented development of the CRF Web EDC tool and associated functionality; supported technology roadmap, QMS documentation and team recruitment; full capability audit with recommendations.

Consultant — Chief Data Officer at RareiTi, UK (2020-05 – 2020-12)

Advised on and implemented a medical technology platform for Rare Diseases; vendor selection, technology roadmap and MVP definition; led platform design and integration of disparate datasets across patient, HCP and client views. Reported to the CEO on best practice, standardisation and regulatory-compliant solutions.

Consultant at Chaucer Consultancy — MHRA, London, UK (2019-10 – 2020-05)

Delivered a UK-wide technical Pharmacovigilance transformation programme for the MHRA; systems, process and organisational change, requirements gathering, technology roadmap and integration of machine learning to future-proof vigilance systems.

Head of Biometrics at MAC Clinical Research, Manchester, UK (2017-10 – 2019-09)

Built, led and managed the Biometrics department — Data Management, Database Programming, Statistical Programming and Statistics — including budget, vendors and CRO activities. Developed best-practice SOPs and the Biometrics QMS; client-facing lead winning new projects and growing the service offering.

Data Manager (Consultant) at Novo Nordisk, Copenhagen, Denmark (2017-04 – 2017-08)

Supported the Data Management and Biometrics function; led technical set-up of an eDiary system alongside external vendor data.

Data Manager (Consultant) at Bavarian Nordic, Munich, Germany (2016-09 – 2017-04)

Managed outsourcing across CROs and service providers; Project Lead for the Integrated Safety Summary for an FDA BLA submission, including vendor selection, costings, RFP and cross-functional coordination (Clinical Operations, Bioanalysis, QC-Development).

Data Manager (Consultant) at Novo Nordisk, Copenhagen, Denmark (2015-07 – 2016-09)

Led EDC set-up of a Chinese Phase 3a diabetes study within the Data Management and Biometrics function.

Project Manager (Consultant) at Synergy Consultancy, Maidenhead, UK (2014-03 – 2015-07)

Acted as Operational Director ahead of a new appointment; managed statisticians and statistical programmers, developed the costing model and led business development, resource planning and SOP input.

Data Management Auditor & Subject Matter Expert (Consultant) at Glenmark Pharmaceutical, Mumbai, India (2014-01 – 2015-02)

Prepared audit plans, conducted a site audit and final report, and trained Biometrics staff to new processes; reviewed all SOPs and prepared staff for a mock MHRA audit.

Senior Analyst (Consultant) at Janssen-Cilag Ltd, High Wycombe, UK (2013-08 – 2014-01)

Supported implementation, validation and rollout of a new regulatory submission database within Global Regulatory Affairs.

Head of Medical Data Management at Idis, Weybridge, UK (2012-09 – 2013-04)

Led Medical Data Management for the Managed Access Programme (Compassionate Use and Orphan Drugs), developing processes, QMS and tools for capturing and reporting real-world medical data; assessed outsourcing vendors.

Head of Data Management & Project Management at Syne qua non, Norfolk, UK (2011-01 – 2012-09)

Line management of 25 direct reports across the largest functional area; owned department SOPs and financial performance, with training delivery and bi-annual QA-aligned SOP cycles.

Associate Project Director at i3 Statprobe, Maidenhead, UK (2008-03 – 2010-04)

Accountable for project profitability, performance, quality and team empowerment; strategic oversight ensuring consistency and quality across projects.

Head of Data Management at Richmond Pharmacology, London, UK (2004-06 – 2008-02)

First Data Manager at Europe's largest Phase I/II CRO; implemented Oracle Clinical and built a cost-effective Data Management group covering Cardiological Sciences and QTc studies; owned Biometrics SOPs and quality activities.

Senior Clinical Data Co-ordinator at Covance, Crawley, UK (1998-10 – 2004-06)

Coordinated global Phase 3 and 4 trials; key client contact and Project Manager, with line management of four Data Managers across four studies and budget responsibility.

Clinical Data Scientist at Quintiles, Battle, UK (1997-03 – 1998-10)

QC and validation of clinical trial data and preparation of client databases leading to drug submission.

PTLLS — Preparing to Teach in the Lifelong Learning Sector – South Downs College, Lewes (2010 – 2010)