Clinical Manager (Cambridge)

Sequential is the world's leading specialist CRO, trusted by more than 100 international brands to unlock the science behind personal care products. Backed by millions of clinical biomarker data points, we help accelerate research and innovation across skin, scalp, oral, intimate care, and supplements.

ROLE SUMMARY

The Clinical Manager will own the end-to-end delivery of Sequential's clinical study portfolio from feasibility and protocol development through ethics approval, recruitment, study conduct, database lock and close-out. This is a hands-on, on-site role for an experienced clinical operations professional who can establish robust CRO-standard processes while delivering studies at pace in a growing biotechnology company.

The role will initially support a substantial double-blind, placebo-controlled study involving participant recruitment, repeated on-site visits, skin imaging and biophysical assessments, electronic data capture, adverse-event oversight, biological sample collection and long-term study archiving. The Clinical Manager will also build reusable systems for future projects of a similar scale and complexity.

KEY RESPONSIBILITIES

Study leadership and delivery

• Lead the planning, set-up, execution and close-out of all in-house and externally supported clinical studies, maintaining clear timelines, budgets, resourcing plans, risk registers and decision logs.
• Translate client objectives into operationally deliverable protocols, schedules of events, recruitment plans, site workflows, study manuals, data-management plans and monitoring plans.
• Coordinate participant visits, clinical equipment, study products, consumables, laboratories, couriers, storage capacity and study-specific vendors so that milestones are met.
• Own day-to-day study governance, including team meetings, client updates, issue escalation, change control and corrective action.
• Manage and develop junior clinical staff and study-specific contractors, ensuring appropriate training, delegation and supervision.

Ethics, regulatory and participant safety

• Lead submissions, amendments, progress reports and close-out notifications to relevant Research Ethics Committees (REC), IRB/IEC bodies, the Health Research Authority and other local or international review bodies as applicable.
• Ensure studies are conducted in accordance with the approved protocol, ICH-GCP principles, applicable UK legislation, sponsor requirements and Sequential SOPs.
• Oversee informed-consent processes, eligibility confirmation, randomisation and blinding controls, adverse-event and serious-adverse-event workflows, protocol deviations and participant withdrawals.
• Maintain oversight of investigational or study-product receipt, labelling, storage, accountability, return and destruction, where applicable.

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

• 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.
• 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.
• 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.