Clinical Manager

SEQUENTIAL PTE. LTD.; Singapore; On-site; SGD 120,000 - 190,000; Full time

Job summary

Sequential Pte. Ltd. seeks an experienced Clinical Manager to own end-to-end delivery of the clinical study portfolio, from feasibility through close-out. This on-site role requires hands-on leadership in a growing biotechnology company.

You will lead study planning, ethics submissions, site coordination and data integrity, building robust CRO-standard processes while delivering studies at pace.

Qualifications

• Experience delivering clinical studies from feasibility to close-out.
• Proven ability to lead cross-functional teams to milestones.
• Strong knowledge of ICH-GCP and SG GDPR.
• Experience with IRB/IEC submissions and regulatory inspections.

Responsibilities

• Lead planning, setup, execution and close-out of studies.
• Coordinate sites, vendors and equipment to meet milestones.
• Oversee data capture, safety reporting and QA activities.
• Maintain trial master file and SOPs; ensure compliance.

Skills

Clinical study leadership

GCP & regulatory compliance

IRB/IEC submissions

Vendor & CRO management

Data management & EDC

Team training & supervision

Study budgeting & planning

Tools

Datacapt

CTMS

Job description

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.