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Biotechnology Research

HEMEX AG

11-50

Join 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.
<h2>Tasks</h2>
<ul>
<li>The Clinical Data Manager is responsible for the planning, setup, conduct, cleaning, reconciliation, and closeout of clinical trial databases.</li>
<li>The role ensures that clinical trial data are complete, consistent, accurate, traceable, and ready for statistical analysis and database lock.</li>
<li>The Clinical Data Manager works closely with Clinical Operations, CRAs, Medical Monitors, Pharmacovigilance, Biostatistics, investigators, and sponsors throughout the study lifecycle.</li>
</ul>
Functional Responsabilities:
1. Study Setup and Database Build
<ul>
<li>Translate clinical trial protocols and endpoints into electronic Case Report Forms (eCRFs).</li>
<li>Develop eCRF specifications in alignment with applicable CDISC (CDASH and SDTM) standards where required.</li>
<li>Develop and maintain the Data Management Plan (DMP), the Data Validation Plan, and the eCRF Completion Guidelines.</li>
<li>Define data handling, data transfer, reconciliation, and data security processes in compliance with applicable data protection requirements (e.g., GDPR and the Swiss FADP).</li>
<li>Develop Edit Check Specifications and automated validation rules.</li>
<li>Support database configuration and testing.</li>
<li>Lead or coordinate User Acceptance Testing (UAT) of the Electronic Data Capture (EDC) system.</li>
<li>Ensure database readiness and documented approval prior to study go-live.</li>
<li>Train investigators and site staff on eCRF completion and EDC use, and support kick-off and investigator meetings as required.</li>
</ul>
2. Study Conduct and Data Cleaning
<ul>
<li>Monitor incoming clinical trial data for completeness, consistency, and quality.</li>
<li>Review data listings and identify missing, inconsistent, or implausible data.</li>
<li>Generate, review, and track data queries to clinical trial sites.</li>
<li>Use 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>
<li>Monitor query resolution and ensure that outstanding discrepancies are appropriately addressed.</li>
<li>Maintain accurate documentation of data cleaning activities.</li>
<li>Prepare 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>
3. External Data Reconciliation
<ul>
<li>Coordinate integration and reconciliation of external data sources with the clinical database.</li>
<li>Define and agree data transfer agreements and specifications with external data vendors.</li>
<li>Reconcile central laboratory data, ePRO/eCOA data, IRT data, imaging data, and other external datasets where applicable.</li>
<li>Ensure that data transfers are complete, accurate, documented, and appropriately version-controlled.</li>
</ul>
4. Medical Coding
<ul>
<li>Coordinate or perform medical coding of:
</li>
<li>Adverse events using MedDRA.
</li>
<li>Medical history using MedDRA.
</li>
<li>Concomitant medications using WHODrug or applicable standards.
</li>
<li>Ensure coding is consistent and appropriately reviewed, and that dictionary versions are documented and upgrades are managed in a controlled manner.
</li>
<li>Resolve coding discrepancies according to predefined procedures.
</li>
</ul>
5. SAE and Safety Data Reconciliation
<ul>
<li>Reconcile 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>
<li>Work closely with Medical Monitors and Pharmacovigilance personnel to investigate discrepancies.</li>
<li>Ensure that safety data are complete and consistent across relevant systems.</li>
</ul>
6. Database Lock and Study Closeout
<ul>
<li>Coordinate the Lock Readiness Review.</li>
<li>Confirm that critical data fields are complete.</li>
<li>Ensure outstanding queries are closed or appropriately justified.</li>
<li>Ensure protocol deviations and relevant data issues are appropriately documented.</li>
<li>Coordinate final clean-file review with CRAs, Medical Monitors, Biostatisticians, and other relevant stakeholders.</li>
<li>Execute or coordinate database lock according to approved procedures.</li>
<li>Prepare data cuts and transfers for interim analyses and DSMB/DMC reviews as required.</li>
<li>Ensure appropriate documentation of database lock activities.</li>
<li>Support archiving and audit readiness, including metadata and audit trail documentation, and filing of data management documents in the Trial Master File (TMF).</li>
<li>Keep documentation and handover notes up to date so that the named backup can cover planned and unplanned absences.</li>
</ul>
<h2>Requirements</h2>
<ul>
<li>Bachelor's or Master's degree in Life Sciences, Clinical Data Management, Pharmacy, Biostatistics, Computer Science, or a related discipline.</li>
<li>At least 2 years of experience in clinical data management within a CRO, pharmaceutical, biotechnology, or medical device environment.</li>
<li>Experience with EDC systems and clinical trial databases.</li>
<li>Knowledge of clinical data management processes and database lifecycle management.</li>
<li>Experience with eCRF development, edit checks, data cleaning, query management, and database lock.</li>
<li>Knowledge of MedDRA and WHODrug preferred.</li>
<li>Knowledge of CDISC (CDASH and SDTM) standards preferred.</li>
<li>Knowledge of ICH-GCP and clinical research regulations (including requirements for computerized systems and electronic records, and data protection).</li>
<li>Experience with R for data cleaning, validation, and listings; Python is an advantage.</li>
<li>Strong attention to detail and data quality mindset.</li>
<li>Structured and process-oriented working style.</li>
<li>Strong organizational and project coordination skills.</li>
<li>Ability to identify and resolve data discrepancies.</li>
<li>Strong communication skills.</li>
<li>Fluent English (written and spoken).</li>
<li>Ability to work effectively across Clinical Operations, Pharmacovigilance, Medical Monitoring, and Biostatistics.</li>
<li>Strong commitment to SOP compliance and continuous improvement.</li>
<li>Ability to manage multiple studies and competing priorities.</li>
</ul>
<h2>Benefits</h2>
Flexible working arrangements and hybrid work options Modern, international and entrepreneurial working environment 
Opportunities for professional growth and continuous learning 
High level of autonomy and responsibility 
Collaborative team culture with direct communication and short decision-making paths 
Central location with good public transport connections 
Opportunity to work with innovative companies and projects in a dynamic industry
Join 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.

Our other open positions

Medical Monitor /Pharmacovigilance & Medical Device Safety min 50%