Clinical Manager

The Clinical Manager will own the end-to-end delivery of Sequential's clinical studyportfolio 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 canestablish robust CRO-standard processes while delivering studies at pace in agrowing biotechnology company.

The role willinitially support a substantial double-blind, placebo-controlled studyinvolving participant recruitment, repeated on-site visits, skin imaging andbiophysical 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 scaleand complexity.

KEY RESPONSIBILITIES

Study leadership and delivery

· Lead the planning, set-up,execution and close-out of all in-house and externally supported clinicalstudies, maintaining clear timelines, budgets, resourcing plans, risk registersand decision logs.

· Translate client objectivesinto operationally deliverable protocols, schedules of events, recruitmentplans, site workflows, study manuals, data-management plans and monitoringplans.

· 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 studygovernance, including team meetings, client updates, issue escalation, changecontrol and corrective action.

· Manage and develop juniorclinical 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 IRB/IEC bodies, the Health Research Authority and other localor international review bodies as applicable.

· Ensure studies are conducted inaccordance with the approved protocol, ICH-GCP principles, applicable SG legislation, sponsor requirements and Sequential SOPs.

· Oversee informed-consentprocesses, eligibility confirmation, randomisation and blinding controls,adverse-event and serious-adverse-event workflows, protocol deviations andparticipant withdrawals.

· Maintain oversight ofinvestigational or study-product receipt, labelling, storage, accountability,return and destruction, where applicable.

Recruitment and siteoperations

· Develop realistic recruitmentand 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 hydrationmeasurements, elasticity testing, questionnaires, diaries and biological samplecollection.

· Ensure study rooms, instrumentsand consumables are ready for use, with documented calibration, maintenance,cleaning and environmental controls where required.

· Monitor recruitment, visitcompletion, missed visits, attrition and data completeness, intervening earlywhen performance falls behind plan.

Data, systems and confidentiality

· Own the set-up and controlleduse of electronic clinical systems, including Datacapt or comparable EDC/eCRFplatforms, electronic trial master files, CTMS tools and ISO-alignedquality-management software.

· Work with data and laboratoryteams to define CRFs, data dictionaries, edit checks, data-transferspecifications, sample identifiers, reconciliation processes and database-lockcriteria.

· Ensure source data, eCRF data,images, questionnaires and laboratory records are accurate, attributable,complete and traceable.

· Maintain appropriateconfidentiality, role-based access, audit trails, retention controls and datahandling in line with SG GDPR, participant consent and contractual obligations.

Quality, audit and inspection readiness

· Maintain a complete andinspection-ready Trial Master File and Investigator Site File, includingtraining, delegation, approvals, monitoring, safety, data and vendordocumentation.

· Develop and maintain clinicalSOPs, work instructions, templates and quality records suitable for a growingCRO environment.

· Lead internal quality reviewsand host sponsor audits, client visits and regulatory or ethics inspections;track findings through CAPA to effective closure.

· Ensure study records andsamples 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 studydesign, sample handling, analytical plans and reporting remain aligned.

· Support proposal development,feasibility assessments, scope definition, project costing and clientdiscussions for future clinical programmes.

· Manage external sites,laboratories, recruiters, consultants and other vendors against agreed scope,quality, timelines and budget.

· Contribute to final clinicalstudy reports, client presentations and lessons-learned reviews.