27 jobs within 10 miles of Maidenhead
Acts as case management subject matter expert for assigned clinical trials, overseeing safety reporting plans, vendor performance and ICSR compliance. Leads pharmacovigilance processes, supports GxP inspections and audits, and provides study-specific training to vendors and internal teams. Requires deep PV and regulatory knowledge in a multinational pharmaceutical setting.
Drug Safety Database
Leads the full statistical contribution to a clinical development programme, defining statistical strategy for trial design, analysis and regulatory submissions, and representing Biostatistics in interactions with the FDA, EMA and PMDA. Also manages outsourcing to CROs/FSPs and contributes to governance and development-plan decisions across therapeutic areas.
SAS · R
Fortrea
Monitors and oversees clinical trial sites across the Midlands, handling site initiation, monitoring visits and closeouts while ensuring GCP compliance and patient safety. Also supports feasibility assessments, investigator recruitment, vendor coordination, SAE reporting and mentoring of junior team members within a global FSP team.
Fortrea
Conducts and oversees site monitoring visits, managing site initiation, monitoring and closeouts while ensuring patient safety, data integrity and GCP compliance. Supports feasibility assessments, investigator recruitment and vendor coordination, and mentors junior team members. Requires Phase I patient-study experience within a client-dedicated FSP team.
Johnson & Johnson Innovative Medicine
A 12-week summer internship in EMEA Global Regulatory Affairs within the Oncology therapeutic area, working on a hybrid model with three days on site. Interns join a global matrixed team supporting clinical strategies and Phase I-III oncology studies, contributing to regulatory strategy, clinical trial applications and product registration activities, with a mentor, cross-functional team meetings and a research poster presented at a company-wide symposium.
Microsoft Outlook · Microsoft Excel · Microsoft PowerPoint +5
Johnson & Johnson Innovative Medicine
Supports the Local Trial Manager and Site Manager with document management and administrative tasks across trial start-up, execution and close-out, ensuring compliance with SOPs and local regulatory requirements. Also contributes to process improvement, training and mentoring of other CTAs, partnering with Business Operations, study teams and stakeholders such as Finance and Procurement.
Microsoft Word · Microsoft PowerPoint · Microsoft Excel
Oversees vendor delivery of medical evaluations for individual case safety reports, applying medical and scientific judgment on causality, expectedness and seriousness. Trains Medical Evaluators, sets assessment frameworks and drives process improvements across Global Safety and Pharmacovigilance. Requires deep pharmacovigilance knowledge and cross-functional stakeholder work.
CSL · 10001+ people · Public
Leads safety surveillance and signal detection across a product's lifecycle, reviewing clinical and post-marketing data and contributing to aggregate safety reports and risk management plans. Partners with Global Safety Leads and cross-functional teams, mentors junior scientists, and supports regulatory responses.
Microsoft Excel
CSL · 10001+ people · Public
Leads a cross-functional Clinical Development Team as the lead scientific expert, owning the clinical strategy, plan and medical monitoring for immunoglobulin programs. Accountable for clinical content of regulatory submissions and study documents, and serves as medical monitor across trials in a matrixed environment.
Provides medical and scientific expertise on clinical safety across the full product lifecycle, with emphasis on evaluating safety data during clinical development and post-approval. Chairs the Safety Management Team, oversees signal detection, aggregate reports (DSURs, PSURs, RMPs) and regulatory responses, and sets safety strategy for global cross-functional development and post-marketing teams.
DSUR · PSUR · RMP +2
Leads strategic sourcing and evaluation of late-stage external clinical assets in Immunology, from Phase 2 through marketed drugs, as the senior S&E leader within the Therapy Area Leadership Team. Drives proactive sourcing, cross-functional due diligence, and KOL engagement, partnering with BD to advance high-priority opportunities through negotiation and deal close.
Fortrea
Leads clinical data management for one or more oncology studies within a sponsor-dedicated (FSP) model, acting as the primary client contact from study set-up through close-out. Combines strategic oversight of vendors, budgets and CDM deliverables with hands-on work such as eCRF design and data cleaning, collaborating with data coordinators and statistical programmers.
eCRF
Fortrea
Monitoring investigator sites across the North of England for a routine post-market surveillance study within a dedicated FSP model. Involves on-site and remote monitoring, building relationships with investigators, and ensuring patient safety, data quality and regulatory compliance, with travel to Oxford at least monthly plus on-site onboarding and training.
Fortrea
Technical lead for all data management activities on late phase (IIb-III) clinical trials, from start-up through completion. Develops Data Management and Quality Management Plans, designs CRF/eCRF and database structures, and coordinates edit checks and discrepancy management. Acts as client liaison, tracking cycle times and metrics while overseeing data review staff.
RAVE · EDC
Fortrea
Lead and manage clinical trial sites across a diverse portfolio spanning oncology, neuroscience, cell & gene and CAR-T therapies. The role emphasises patient safety, data integrity and building trusted relationships with investigators, with autonomy and support for complex, innovative study designs.
