Clinical Data Manager 50%

pJoin HEMEX, A European Contract Research Organization based in Liestal, Switzerland, dedicated to advancing global healthcare through innovative biotechnology research. As a Medical Monitor specializing in Pharmacovigilance and Medical Device Safety, you'll play a crucial role in ensuring the safety and efficacy of groundbreaking pharmaceutical, biotech, and medtech solutions. With our comprehensive clinical development services, including regulatory support and quality assurance, you'll have the opportunity to work on multinational clinical trials and contribute to the translation of novel concepts into market-ready solutions. /p h3Tasks /h3 ul liThe Clinical Data Manager is responsible for the planning, setup, conduct, cleaning, reconciliation, and closeout of clinical trial databases. /li liThe role ensures that clinical trial data are complete, consistent, accurate, traceable, and ready for statistical analysis and database lock. /li liThe Clinical Data Manager works closely with Clinical Operations, CRAs, Medical Monitors, Pharmacovigilance, Biostatistics, investigators, and sponsors throughout the study lifecycle. /li /ul pFunctional Responsabilities: /p pb1. Study Setup and Database Build /b /p ul liTranslate clinical trial protocols and endpoints into electronic Case Report Forms (eCRFs). /li liDevelop eCRF specifications in alignment with applicable CDISC (CDASH and SDTM) standards where required. /li liDevelop and maintain the Data Management Plan (DMP), the Data Validation Plan, and the eCRF Completion Guidelines. /li liDefine data handling, data transfer, reconciliation, and data security processes in compliance with applicable data protection requirements (e.g., GDPR and the Swiss FADP). /li liDevelop Edit Check Specifications and automated validation rules. /li liSupport database configuration and testing. /li liLead or coordinate User Acceptance Testing (UAT) of the Electronic Data Capture (EDC) system. /li liEnsure database readiness and documented approval prior to study go-live. /li liTrain investigators and site staff on eCRF completion and EDC use, and support kick-off and investigator meetings as required. /li /ul pb2. Study Conduct and Data Cleaning /b /p ul liMonitor incoming clinical trial data for completeness, consistency, and quality. /li liReview data listings and identify missing, inconsistent, or implausible data. /li liGenerate, review, and track data queries to clinical trial sites. /li liUse R programming to support data cleaning, validation, and preparation of clean datasets for Biostatistics, preferably following SDTM standards (ADaM derivations remain with Biostatistics), with appropriate documentation and quality control. /li liMonitor query resolution and ensure that outstanding discrepancies are appropriately addressed. /li liMaintain accurate documentation of data cleaning activities. /li liPrepare data management status and metrics reports (e.g., query rates, data-entry timelines) for the project team and sponsors, and support risk-based quality management. /li /ul pb3. External Data Reconciliation /b /p ul liCoordinate integration and reconciliation of external data sources with the clinical database. /li liDefine and agree data transfer agreements and specifications with external data vendors. /li liReconcile central laboratory data, ePRO/eCOA data, IRT data, imaging data, and other external datasets where applicable. /li liEnsure that data transfers are complete, accurate, documented, and appropriately version-controlled. /li /ul pb4. Medical Coding /b /p ul liCoordinate or perform medical coding of: /li liAdverse events using MedDRA. /li liMedical history using MedDRA. /li liConcomitant medications using WHODrug or applicable standards. /li liEnsure coding is consistent and appropriately reviewed, and that dictionary versions are documented and upgrades are managed in a controlled manner. /li liResolve coding discrepancies according to predefined procedures. /li /ul pb5. SAE and Safety Data Reconciliation /b /p ul liReconcile serious adverse events between the clinical database (EDC) and the pharmacovigilance/safety database at agreed intervals and prior to interim analyses and database lock. /li liWork closely with Medical Monitors and Pharmacovigilance personnel to investigate discrepancies. /liliEnsure that safety data are complete and consistent across relevant systems. /li /ul pb6. Database Lock and Study Closeout /b /p ul liCoordinate the Lock Readiness Review. /li liConfirm that critical data fields are complete. /li liEnsure outstanding queries are closed or appropriately justified. /li liEnsure protocol deviations and relevant data issues are appropriately documented. /li liCoordinate final clean-file review with CRAs, Medical Monitors, Biostatisticians, and other relevant stakeholders. /li liExecute or coordinate database lock according to approved procedures. /li liPrepare data cuts and transfers for interim analyses and DSMB/DMC reviews as required. /li liEnsure appropriate documentation of database lock activities. /li liSupport archiving and audit readiness, including metadata and audit trail documentation, and filing of data management documents in the Trial Master File (TMF). /li liKeep documentation and handover notes up to date so that the named backup can cover planned and unplanned absences. /li /ul h3Requirements /h3 ul liBachelor's or Master's degree in Life Sciences, Clinical Data Management, Pharmacy, Biostatistics, Computer Science, or a related discipline. /li liAt least 2 years of experience in clinical data management within a CRO, pharmaceutical, biotechnology, or medical device environment. /li liExperience with EDC systems and clinical trial databases. /li liKnowledge of clinical data management processes and database lifecycle management. /li liExperience with eCRF development, edit checks, data cleaning, query management, and database lock. /li liKnowledge of MedDRA and WHODrug preferred. /li liKnowledge of CDISC (CDASH and SDTM) standards preferred. /li liKnowledge of ICH-GCP and clinical research regulations (including requirements for computerized systems and electronic records, and data protection). /li liExperience with R for data cleaning, validation, and listings; Python is an advantage. /li liStrong attention to detail and data quality mindset. /li liStructured and process-oriented working style. /li liStrong organizational and project coordination skills. /li liAbility to identify and resolve data discrepancies. /li liStrong communication skills. /li liFluent English (written and spoken). /li liAbility to work effectively across Clinical Operations, Pharmacovigilance, Medical Monitoring, and Biostatistics. /li liStrong commitment to SOP compliance and continuous improvement. /li liAbility to manage multiple studies and competing priorities. /li /ul h3Benefits /h3 pFlexible working arrangements and hybrid work optionsbr/Modern, international and entrepreneurial working environment /p pOpportunities for professional growth and continuous learning /p pHigh level of autonomy and responsibility /p pCollaborative team culture with direct communication and short decision-making paths /p pCentral location with good public transport connections /p pOpportunity to work with innovative companies and projects in a dynamic industry /p pJoin HEMEX AG as a Clinical Data Manager (50%) to drive innovation in global healthcare. Collaborate on multinational trials with a leading European CRO in a dynamic, supportive environment. /p #J-18808-Ljbffr