Clinical Data Systems Professional

Strategic consultant guiding the implementation and validation of software for mission‑critical trials.

Portfolio

Nicola Lees Professional Overview

A seasoned implementation leader with extensive experience delivering large-scale ERP and enterprise software solutions across global organisations. Skilled in managing full project lifecycles — from scoping and configuration through to go-live and hypercare — while keeping business objectives firmly in focus. Experienced in coordinating multi-disciplinary teams and aligning technical delivery to real-world operational needs. A trusted partner to organisations navigating complex system transitions.

02

Change Management & User Adoption

An accomplished change practitioner with extensive experience guiding organisations through technology-driven transformation. Skilled in designing and delivering stakeholder engagement strategies, communications plans, and end-user training programmes that drive meaningful adoption. Experienced in navigating resistance, building buy-in at all levels, and ensuring that new systems embed successfully into day-to-day operations. A people-first approach that keeps the human side of change firmly at the centre.

03

SaaS Clinical Platform Implementation

Led the implementation of a Software as a Service (SaaS) solution for a major clinical platform. Focused on seamless integration and user adoption to enhance clinical trial operations and data management.

04

CSV & Regulatory Validation

An experienced validation professional with a strong background in Computer System Validation across highly regulated industries including life sciences and pharmaceuticals. Adept at developing and executing validation strategies, protocols, and documentation that meet FDA, GAMP 5, and international compliance standards. Skilled in leading audit preparation and engaging confidently with quality and regulatory stakeholders at a senior level. Brings rigour, accountability, and deep compliance knowledge to every engagement.

05

Programme & Project Management

A delivery-focused programme leader with a consistent record of directing complex, multi-workstream projects from initiation through to benefits realisation. Experienced in establishing robust governance structures, managing risk, and maintaining stakeholder confidence throughout the programme lifecycle. Comfortable operating in both agile and waterfall environments across geographically dispersed teams. Known for bringing clarity, structure, and momentum to programmes of significant scale and complexity.

06

MHRA Audit Software Validation

Successfully validated clinical trial software, ensuring compliance and leading to a successful MHRA audit. This project highlights expertise in rigorous validation processes and regulatory adherence specific to clinical trials. Received a company award for recognition of the success of the audit performance for CSV and the implementation of SaaS systems.

Overview

Senior Clinical Software Specialist

20+ years leading clinical trial software delivery

I deliver the systems clinical trials run on. My hands-on experience spans Medidata Rave (certified in study build and administration), Oracle InForm and Central Designer, Veeva eTMF, Clinpal eCOA/ePRO and the Science 37 decentralised trial platform. I configure them around how study teams work and support users through training and go-live. My work covers the full lifecycle, from vendor selection and configuration through to administration, upgrades and inspection support.

Validation Methodologies & Execution

Robust validation frameworks for regulated environments

I validate clinical systems to a standard that stands up to audit and inspection. My experience covers the full validation lifecycle, including Validation Plans, requirements, test scripts, traceability matrices, defect resolution, system release documentation and Validation Summary Reports. I have led validation of hosted SaaS platforms (PQ and UAT), RBQM software ahead of customer deployment, and new releases and upgrades of EDC systems, working to GCP, CSV and 21 CFR Part 11 requirements. I have led teams of testers, managed validation defects with engineers and vendors, and run client testing kick-offs, using tools including TestRail, ALM-QC and Azure DevOps. I also hold the ISEB Foundation Certificate in Software Testing and have supported audits on computerised systems, including an MHRA audit.

Technical Implementation & Compliance

End‑to‑end ownership of clinical software rollouts

I plan, configure and support clinical data systems from initial requirements through go-live and ongoing optimisation, in line with GCP, CSV and 21 CFR Part 11 requirements. My technical work includes specifying requirements, configuring eCRFs and edit checks (using XML, SQL and SAS), managing user access and roles, and integrating platforms such as CTMS, eTMF and EDC. I also run change control and upgrade impact assessments, write the SOPs and training that keep systems compliant in daily use, and manage vendor relationships and contracts.