iTRTech Group

<h4><strong>CLINICAL DATA PROGRAMMER / CLINICAL DATA MANAGER (EDC) (REMOTE ANYWHERE)</strong></h4>
<p>Portuguese company hires for remote position</p>
<p>Location: anywhere</p>
<p>Work Model:100% remote</p>
<p>️ Language Requirements: <strong>English:</strong> B2/C1</p>
<p>Seniority: Mid-level (3+ years)</p>
<p>Sector: HealthTech</p>
<p>Rate Between €2500 - 2800 RV</p>
<ul>
<li>️ Instructions: Please send your CV in English and make sure to include all skills and experience that match the requirements of the opportunity. This will significantly increase your chances of success</li>
</ul>
<h4><strong>The Opportunity</strong></h4>
<p>We are looking for a <strong>Clinical Data Programmer / Clinical Data Manager</strong> to join an innovative HealthTech project focused on the quality, integrity, and effective management of clinical trial data.</p>
<p>You will work across the complete clinical data lifecycle, from study start-up and database design to testing, data cleaning, reconciliation, and database lock. The role combines traditional Clinical Data Management activities with EDC configuration, clinical programming, project coordination, and stakeholder engagement.</p>
<h4><strong>Key Responsibilities</strong></h4>
<p><strong>Clinical Data Management</strong></p>
<ul>
<li>Support clinical data management initiatives throughout the study lifecycle;</li>
<li>Translate sponsor and client requirements into comprehensive Data Management Plans;</li>
<li>Ensure the quality, consistency, traceability, and integrity of clinical data;</li>
<li>Design and review Case Report Forms and electronic Case Report Forms;</li>
<li>Perform data cleaning, query management, coding, and clinical event classification;</li>
<li>Conduct Serious Adverse Event reconciliation;</li>
<li>Support database audits and quality-control activities;</li>
<li>Manage clinical database locking and unlocking procedures;</li>
<li>Coordinate data transfers, imports, loading, and integration;</li>
<li>Prepare clinical data for delivery to sponsors and other external parties;</li>
<li>Maintain all required project and regulatory documentation.</li>
</ul>
<p><strong>EDC and System Implementation</strong></p>
<ul>
<li>Configure and implement studies using eClinical or EDC platforms;</li>
<li>Write functional and design specifications for forms, reports, workflows, and system components;</li>
<li>Support the development and maintenance of project infrastructure systems;</li>
<li>Develop and execute system, module, and integration testing strategies;</li>
<li>Plan, coordinate, and perform User Acceptance Testing;</li>
<li>Facilitate the validation of clinical system implementations;</li>
<li>Work with Clinical Data Specialists to implement Data Management Plans;</li>
<li>Support activities on additional clinical technology platforms when required.</li>
</ul>
<p><strong>Clinical Programming and SAS</strong></p>
<ul>
<li>Programme customised data listings, summary tables, and routine graphics;</li>
<li>Interpret study protocols, Statistical Analysis Plans, shells, and templates;</li>
<li>Create SAS datasets from clinical databases;</li>
<li>Develop status, efficacy, and project-specific datasets;</li>
<li>Create project-specific macros and formats;</li>
<li>Document datasets, variables, derived variables, and programming logic;</li>
<li>Prepare programme documentation according to project standards;</li>
<li>Load and transform data received from external platforms and software packages.</li>
</ul>
<p><strong>Project and Stakeholder Coordination</strong></p>
<ul>
<li>Lead or support functional project meetings;</li>
<li>Communicate with sponsors and internal teams regarding timelines, issues, deliverables, and resources;</li>
<li>Coordinate study progress and monitor the quality of deliverables;</li>
<li>Manage multiple clinical data projects and competing priorities;</li>
<li>Collaborate with cross-functional and globally distributed teams;</li>
<li>Ensure project activities are completed accurately and within agreed deadlines.</li>
</ul>
<h4><strong>Mandatory Requirements</strong></h4>
<ul>
<li>Bachelor’s degree or an equivalent combination of education, training, and professional experience;</li>
<li>Minimum of three years of experience in clinical trials, Clinical Data Management, or a closely related area;</li>
<li>Hands-on experience with Electronic Data Capture systems;</li>
<li>Understanding of clinical databases, CRFs, and eCRFs;</li>
<li>Experience across the clinical data lifecycle;</li>
<li>Practical experience with data cleaning and query management;</li>
<li>Experience with system testing and User Acceptance Testing;</li>
<li>Understanding of Good Clinical Data Management Practices and related documentation;</li>
<li>Knowledge of clinical trial protocols, study design, and therapeutic indications;</li>
<li>Strong understanding of database design and structure;</li>
<li>Advanced computer skills, including Microsoft Office;</li>
<li>Strong attention to detail and accuracy;</li>
<li>Excellent organisational and prioritisation skills;</li>
<li>Ability to manage multiple projects and meet deadlines;</li>
<li>Ability to work independently and take ownership;</li>
<li>Strong collaboration and stakeholder communication skills;</li>
<li>English proficiency at B2/C1 level.</li>
</ul>
<h4><strong>Highly Valued Experience</strong></h4>
<ul>
<li>Responsibility for the complete data management lifecycle of a clinical trial;</li>
<li>SAS programming experience;</li>
<li>Creation of SAS clinical datasets, macros, formats, listings, and summary tables;</li>
<li>Experience interpreting Statistical Analysis Plans;</li>
<li>Clinical coding dictionary experience;</li>
<li>Serious Adverse Event reconciliation;</li>
<li>Database lock and unlock activities;</li>
<li>Data transfer and integration experience;</li>
<li>Project management or team leadership responsibilities;</li>
<li>Experience working directly with clinical trial sponsors;</li>
<li>Experience in changing, high-pressure, or highly regulated environments.</li>
</ul>
<h4><strong>Ideal Candidate Profile</strong></h4>
<p>The ideal candidate combines practical Clinical Data Management experience with strong technical knowledge of EDC systems and clinical databases. You understand how clinical data moves through the complete study lifecycle and can translate protocol and sponsor requirements into reliable systems, processes, and documentation.</p>
<p>You are detail-oriented, organised, and comfortable balancing multiple projects. You can independently manage data cleaning, testing, UAT, reconciliation, and database lock activities while maintaining a strong focus on quality and regulatory compliance.</p>
<p>You communicate effectively with sponsors, clinical teams, programmers, and other stakeholders. Experience with SAS and end-to-end ownership of a clinical trial’s data management lifecycle will make you particularly well suited to this opportunity.</p>
<h4><strong>Why Consider This Opportunity?</strong></h4>
<ul>
<li>Work on meaningful clinical research and HealthTech projects;</li>
<li>Participate in the complete clinical data lifecycle;</li>
<li>Combine Clinical Data Management, EDC implementation, and programming activities;</li>
<li>Collaborate directly with sponsors and international cross-functional teams;</li>
<li>Take ownership of quality and integrity within final clinical databases;</li>
<li>Develop experience across multiple clinical systems and therapeutic areas;</li>
<li>Benefit from a fully remote working model.</li>
</ul>
<h4><strong>Questions for Candidates</strong></h4>
<p>When applying, please address the following questions in your CV or application message:</p>
<ul>
<li>How many years of experience do you have in clinical trials or Clinical Data Management?</li>
<li>Which EDC or eClinical platforms have you used?</li>
<li>Have you managed the complete data lifecycle of a clinical trial?</li>
<li>What experience do you have designing CRFs or eCRFs?</li>
<li>Have you created or implemented Data Management Plans?</li>
<li>What data cleaning, query management, coding, and SAE reconciliation activities have you performed?</li>
<li>What experience do you have with system testing and User Acceptance Testing?</li>
<li>Have you participated in clinical database lock and unlock processes?</li>
<li>What experience do you have with clinical data transfers, imports, and integrations?</li>
<li>Have you led Clinical Data Management projects or functional meetings?</li>
<li>Do you have practical SAS programming experience?</li>
<li>Have you created SAS datasets, macros, listings, summary tables, or graphics for clinical studies?</li>
<li>Have you worked with study protocols and Statistical Analysis Plans?</li>
<li>What is your level of written and spoken English?</li>
<li>Is the €2,500–€2,800 compensation range under an RV or single-member company arrangement aligned with your expectations?</li>
<li>Are you available to work on a fully remote basis?</li>
</ul>
<h4><strong>Recommended CV Keywords</strong></h4>
<p>Clinical Data Programmer, Clinical Data Manager, Clinical Data Management, Clinical Trials, Clinical Research, HealthTech, EDC, Electronic Data Capture, eClinical, Clinical Database, Database Design, CRF, eCRF, Case Report Form, Clinical Data Lifecycle, Data Management Plan, DMP, Good Clinical Data Management Practices, GCDMP, Data Cleaning, Data Queries, Query Management, Clinical Coding, Coding Dictionaries, SAE Reconciliation, Serious Adverse Event Reconciliation, Clinical Event Classification, Database Audit, Database Lock, Database Unlock, Data Quality, Data Integrity, Data Validation, System Testing, Module Testing, User Acceptance Testing, UAT, Data Transfer, Data Loading, Data Integration, Clinical Data Specialist, Sponsor Management, Project Management, Study Start-Up, Study Close-Out, Clinical Programming, SAS, SAS Programming, SAS Datasets, Clinical Datasets, Status Datasets, Efficacy Datasets, SAS Macros, SAS Formats, Data Listings, Summary Tables, Statistical Analysis Plan, SAP, Clinical Protocol, Derived Variables, Programme Documentation, Regulatory Documentation, Microsoft Office</p>
<p>#00352227</p>


CLINICAL DATA PROGRAMMER / CLINICAL DATA MANAGER (EDC) (REMOTE)

CLINICAL DATA PROGRAMMER / CLINICAL DATA MANAGER (EDC) (REMOTE)

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