Recruitment and site operations

• Develop realistic recruitment and retention strategies, including pre-screening, participant communications, scheduling, visit reminders, reimbursement, and study-compliance follow-up.
• Create efficient, participant-centred on-site workflows for imaging, skin barrier and hydration measurements, elasticity testing, questionnaires, diaries, and biological sample collection.
• Ensure study rooms, instruments, and consumables are ready for use, with documented calibration, maintenance, cleaning, and environmental controls where required.
• Monitor recruitment, visit completion, missed visits, attrition, and data completeness, intervening early when performance falls behind plan.

Data, systems, and confidentiality

• Own the set-up and controlled use of electronic clinical systems, including Datacapt or comparable EDC/eCRF platforms, electronic trial master files, CTMS tools, and ISO-aligned quality-management software.
• Work with data and laboratory teams to define CRFs, data dictionaries, edit checks, data-transfer specifications, sample identifiers, reconciliation processes, and database-lock criteria.
• Ensure source data, eCRF data, images, questionnaires, and laboratory records are accurate, attributable, complete, and traceable.
• Maintain appropriate confidentiality, role-based access, audit trails, retention controls, and data handling in line with UK GDPR, participant consent, and contractual obligations.

Quality, audit, and inspection readiness

• Maintain a complete and inspection-ready Trial Master File and Investigator Site File, including training, delegation, approvals, monitoring, safety, data, and vendor documentation.
• Develop and maintain clinical SOPs, work instructions, templates, and quality records suitable for a growing CRO environment.
• Lead internal quality reviews and host sponsor audits, client visits, and regulatory or ethics inspections; track findings through CAPA to effective closure.
• Ensure study records and samples are archived or disposed of in accordance with the protocol, contract, applicable regulations, and retention schedule.

Cross-functional and commercial delivery

• Partner with laboratory, bioinformatics, statistics, and commercial colleagues to ensure that study design, sample handling, analytical plans, and reporting remain aligned.
• Support proposal development, feasibility assessments, scope definition, project costing, and client discussions for future clinical programmes.
• Manage external sites, laboratories, recruiters, consultants, and other vendors against agreed scope, quality, timelines, and budget.
• Contribute to final clinical study reports, client presentations, and lessons-learned reviews.

EXPERIENCE AND QUALIFICATIONS

Essential

• Bachelor's degree in life sciences, clinical research, pharmacy, nursing, or a related discipline; a postgraduate qualification is advantageous.
• At least five years' experience in clinical operations, including meaningful responsibility for end-to-end study delivery and at least two years managing studies or workstreams.
• Strong CRO, sponsor, or clinical-trials-unit experience, with evidence of managing multiple concurrent studies, stakeholders, and vendors.
• Practical experience of ethics and regulatory submissions, informed consent, participant recruitment, monitoring, data cleaning, database lock, and study close-out.
• Current working knowledge of ICH-GCP, UK clinical research governance, UK GDPR, and audit/inspection expectations.
• Experience with EDC/eCRF systems, eTMF or document-management systems, and electronic QMS platforms.
• Excellent organisation, judgement, and communication, with the confidence to identify risks early and drive issues to resolution.
• Willingness to work on site at Babraham Research Campus and to be hands-on during periods of active participant recruitment and study visits.

Desirable

• Experience in dermatology, cosmetics, nutraceuticals, microbiome research, consumer health, or non-CTIMP interventional studies.
• Experience with skin imaging or biophysical instruments such as VISIA, VapoMeter, TEWL, moisture, or elasticity devices.
• Experience establishing or improving clinical SOPs and quality systems within an early-stage or scaling biotechnology company.
• Formal project-management training or certification.

WHAT YOU GET FROM SEQUENTIAL

• A market-aligned base salary and participation in Sequential's Equity Incentive Plan.
• A high-ownership role building the clinical operations capability of a growing biotechnology company.
• Direct collaboration with scientists, clinicians, laboratory teams, data scientists, and international clients.
• Support for relevant professional development, GCP refreshers, and role-specific training.
• The opportunity to shape clinical systems and studies that sit at the intersection of microbiome science, biomarkers, and consumer health.