Donald Diffang

Fully accountable for trial delivery from protocol through CSR, including strategic start-up activities and cross-functional operational feasibility. Led budgeting, vendor oversight, TMF (vTMF) quality reviews, inspection readiness, Health Authority submissions, and successful study close-down with data outputs and database locks.

Delivered Phase I studies on-time, within scope and budget, and in compliance with applicable quality standards. Managed project strategy and risk mitigation, maintained project plans and timelines, oversaw project managers as needed, and managed budgets, profitability, invoicing, and client relationships.

Managed execution of Clinical Trial/Study for Phase IIIb/IV programs according to approved timelines and MMV SOPs and ICH GCP. Oversaw study management activities including supply and vendor management, site initiation, monitoring, essential document management, closedown and archiving, and coordinated CRO oversight and study documentation.

Managed Phase I–III project delivery by maintaining scope and performing proactive risk management and contingency planning. Led project team meetings, managed project timelines and resources, supported protocol development and CRF design, and handled vendor management, contracts, and budget tracking.

Led clinical operations activities across Phase I–III study start-up, conduct, and closeout, including feasibility and vendor capacity assessment. Supervised CROs and external service providers, supported data quality via CRA coordination, managed site payments and study budgets/timelines, maintained TMF completeness for audit/inspection readiness, and supported internal audits and resolution of f

Planned, set up, monitored, executed, and finalized Phase I–III trials while coordinating cross-functional activities. Authored clinical development plans and contributed to regulatory documentation (CTD clinical sections), while supporting GCP inspection preparation, audit planning, and project accounting including budget control and risk escalation.

Provided direction and leadership to study teams for cross-functional delivery against study plans, budgets, timelines, and quality standards. Managed study budgets and forecasting accuracy, resourcing plans, vendor and CRO performance, risk and quality plans, safety reporting oversight, drug supply availability, data quality activities, and study debriefs/best practice improvements.

Accountable for global Phase III trial activities, translating clinical development plans into protocols and related documents. Led matrix management of Clinical Trial Teams, ensured deliverables met timelines/budget/quality, oversaw medical/scientific review and reporting outputs, and managed outsourcing specifications, resource forecasting, and standards for clinical dossiers and regulatory docu

Managed pivotal global Phase III/IV endpoint-driven clinical studies across multiple regions, including resource and budget management to improve patient recruitment. Served as key contact for vendor selection and contract negotiation/oversight, ensured adherence to protocol, SOPs, and GCP, managed drug and clinical supplies, coordinated feasibility through site start-up/closure, and supported mon

Developed EU medical communication activities and programs/materials and managed project execution for symposia in line with Medical Affairs and brand plans. Produced medical/scientific presentations and training materials, supported publication plans, and reviewed/approved educational and promotional content according to SOPs and legal regulations.

Coordinated global clinical study project plans to meet timelines, budgets, performance quality, and delivery coordination requirements. Managed creation, submission, and archiving of study documentation for Health Authorities and Ethics Committees, including investigator selection coordination, study drug supply coordination, monitoring support, and status reporting.

Coordinated and performed quality control activities for clinical device trials, including literature research and clinical data validation. Prepared and delivered presentations, contributed to final reports and scientific publications, and ensured study document archiving and clinical image assessment.

Supported multinational Phase IV clinical trial activities across the European Union in accordance with company policies, SOPs, LWIs, and ICH GCP. Contributed to protocol and amendment/timeline development support, trial meeting coordination and progress reporting, standardized processes, and participated in a European Medico Marketing Phase IV forum strategy focused on transparency and best-pract

Processed license applications for new products, variations, renewals, and clinical trials and supported GCP/GMP/GLP compliance unit planning activities. Performed data analysis and budget forecasting, and prepared and revised internal reports/guidelines/SOPs for submission to the FDA and EMEA.

Reviewed and verified information from multicentre clinical studies, tracking eligibility, enrolment, safety, and data consistency. Performed quality control of statistical data outputs and prepared study and regulatory documentation including CRF design and instruction materials in support of clinical operations and data management.

Completed an M.Sc. in Biopharmacy at King's College London from 1997 to 1999.

Earned a B.Sc. (Hons) in Medicinal Chemistry at Kingston University, with a final-year thesis on organic synthesis and evaluation of an antihypertensive Cromakalim analogue.

Completed A-level studies in Maths, Chemistry, and Art from 1991 to 1994.

Completed GCSEs across subjects including Art, Biology, Chemistry, Economics, English, French, Maths, and Physics from 1986 to 1991.