Barcelona, Catalonia, Spain
Protocols are integral to a trial's success. In the current research landscape, protocol development teams need to develop a protocol that not only aligns with regulatory requirements but is also flexible, attractive to participants, and designed to provide actionable data. I lead Parexel's protocol development best practice and strategies for advancing data-informed decision making. To achieve this I lead a team of protocol specialists that work with trial teams to develop protocols that are clear, precise, practical and consistent. Digital protocols are also in focus as organizations look towards more efficient clinical trial conduct against a backdrop of rising complexity and cost. I am the former business lead for Parexel's Structured Content Authoring platform (2021-2024) and am now leading protocol digitization efforts, including vendor assessments and internal tool deployments. I also teach the next generation of researchers at the London School of Hygiene and Tropical Medicine on Protocol Development and Trial Designs.
• Clinical Trial Protocol Specialist Team Lead • Protocol digitization lead • Supporting clients with protocol development, ICH M11 adoption, standards & process
• Clinical Trial Protocol Specialist Team Lead • Protocol digitization lead (e.g., AI tool integration, vendor assessments) • Lead subject matter expert (SME) for protocol regulatory documents, master protocol/complex innovative design studies, decentralized clinical trials. • Former business owner for Parexel's Structured Content Authoring platform. • Protocol SME team lead for multiple client partnerships. • Understand the challenges clients face in getting therapies to market and propose solutions how to overcome such challenges. • Use awareness of opportunities in the industry to present innovative new trial and drug development strategies to clients. • Build and maintain collaborative client relationships, to cultivate efficient, productive, and professional working partnerships that promote satisfaction and confidence. Act as a trusted advisor to clients. • Actively cultivate a broad range of internal and external networked partners that enable more effective collaboration with other business elements to fully leverage the Parexel brand capabilities.
In addition to Senior Medical Writer responsibilities: • Project leader for Structured Content Management solution implementation • Co-lead for a Parexel Complex Innovative Design Expertise Group • Protocol Subject Matter Expert (SME) for Medical Writing Services (MWS) • Protocol SME for a full service partnership • Master Protocol/Complex Innovative Design study SME • Decentralised Trial Design SME
Supporting PG Cert/PG Dip/MSc Clinical Trial student learning and contributing to the teaching and assessment process
• Develop, review and coordinate the production of clinical documents for regulatory submission (Europe and US), in accordance with standard operating procedures and international guidelines. • Scientific review of Medical Communication material (Europe and Canada). • Review of documents prepared by other writers before internal or external distribution, including both copyediting and content review. • Act as the primary client contact under departmental supervision and as the Medical Writing representative on assigned project teams. • Provide proactive support to Project Management for planning efficient work plans and timelines for Medical Writing deliverables. • Provide Medical Writing input for other departmental deliverables including case report forms (CRFs), data validation plans (DVPs), and statistical analysis plans (SAPs). • Provide training and guidance to junior Medical Writers. • Contribute to the development of in-house guidance documents, templates, and standard operating procedures.
• Develop clinical documents for regulatory submission, in accordance with standard operating procedures and international guidelines. • Scientific review of Medical Communication material (Europe and Canada). • Review of documents prepared by other writers before internal or external distribution, including both copyediting and content review.
Scientific & Editorial review of manuscripts, Ph.D. theses, and research grants Grant writing
A continuation of the work carried out as a Ph.D. student
Development of a novel Genetically Encoded Fluorescent Biosensor using molecular biology and cell culture validation.