Job DescriptionThe Clinical QC Consultant is responsible for ensuring the quality, accuracy, and compliance of clinical trial documentation and data. This role supports clinical operations by performing quality control reviews and ensuring adherence to regulatory requirements and internal standards.Key ResponsibilitiesPerform QC review of clinical documents, including:Clinical study reports (CSRs)Protocols and protocol amendmentsInformed consent forms (ICFs)Monitoring visit reportsTrial master file (TMF) documentsEnsure compliance with:Food and Drug Administration (FDA) regulationsInternational Council for Harmonisation (ICH) guidelinesGood Clinical Practice (GCP) standardsVerify data accuracy and consistency across clinical systems (e.g., EDC, CTMS, TMF)Identify discrepancies, errors, or missing information and communicate findings to clinical teamsEnsure proper documentation, version control, and audit readinessSupport inspection readiness activities and participate in internal auditsCollaborate with cross-functional teams including Clinical Operations, Data Management, and Regulatory AffairsAssist in the preparation of protocols (including the writing of administrative letters for protocols and summary of changes for protocol amendments) and CSRs.Assist in the preparation of study-level documentation required for clinical trials (e.g., CSR appendices, shell drafts)Edit CSR statistical analysis plans and table/figure/listing specifications for grammar, format, and consistency.Support authoring of protocols, investigator brochures, CSRs and other study-level documentation required for clinical trials.Edit submission documents (sections of CSRs, IND/CTA, NDA, MAA, requests for information and briefing documents, etc.) for regulatory agencies.Reviews CSR statistical analysis plans and table/figure/listing specifications for grammar, format, and consistency.Required QualificationsBachelor's degree in Life Sciences, Pharmacy, Nursing, or related field5+ years of experience in clinical research, QA/QC, or clinical operationsStrong knowledge of FDA regulations, ICH guidelines, and GCPExperience reviewing clinical trial documentation and TMF managementHigh attention to detail and strong analytical skillsPreferred QualificationsExperience in hepatology or rare disease clinical trials (relevant to focus areas)Prior experience in a biotech or pharmaceutical companyFamiliarity with electronic systems such as Veeva Vault, Medidata, or similarKey SkillsQuality control and audit readinessDocumentation review and complianceCommunication and collaborationProblem-solving and critical thinkingWork EnvironmentContract/consultant roleRemote or hybrid (depending on project needs)May require collaboration across global teams
about 1 month ago