Clinical Data Manager
Posted: 2 days ago
Job Description
We're hiring: Clinical Data Manager (remote) Are you passionate about improving the way clinical trials are run? We're looking for a Clinical Data Manager to join our team remotely and help shape the future of clinical data workflows through innovative, tech-enabled solutions. Location: Remote (work from home – based in Serbia) Job Type: Full-time Reports to: Senior Manager Clinical Data Operations Experience: 3–5 years in the clinical research industry Languages: Fluent in English (written & spoken) About the role: This is a great opportunity for a highly motivated individual, who has worked as a Clinical Data Manager and/or in CTMS setup or configuration, —and is looking to join a dynamic team supporting Sponsors, CROs, and software development. You'll be directly involved in all aspects of clinical data management processes using our next-generation clinical data management platform. You will be collaborating with cutting-edge sponsors and a multidisciplinary internal team that includes biostatisticians, medical researchers, and a high performing internal software development team. You’ll also gain exposure to, and contribute across, related areas including: Electronic data capture (EDC) integration within a unified clinical research information system Randomization and trial supply management (RTSM) eTMF (electronic trial master file) workflows CTMS eCOA (electronic Clinical Outcome Assessments) eConsent eSource And other integrated clinical technologies What you will do: Translate study protocols into effective, efficient, and comprehensive digital data workflows Design and configure eCRFs and electronic data capture (EDC) forms Support database build activities, including QC and UAT Set up, test, and maintain eCRFs and other EDC document types within the EDC system while integrating them into a unified whole Configure complex edit checks, derivations, and data validation rules Develop comprehensive Data Management Plans (DMPs) and study-specific procedures that include cross functional aspects of data collection and aggregation, including RTSM, ePRO, eConsent, as well as external vendor data such as central labs and/or wearables Help ensure delivery of clean, high-quality clinical trial data Collaborate on improvements to processes and SOPs, documentation, as well as tools and technology development to support project execution Train and mentor junior colleagues and contribute to the overall knowledge base Work cross-functionally with internal and sponsor teams across data, operations, and eClinical technology development Ensure compliance with ICH-GCP, 21 CFR Part 11, and other regulatory requirements Who we are looking for: 3–5 years of experience in the clinical research industry in data management and clinical data technologies (EDC and CTMS) Bachelor’s, Master’s, or PhD degree in Life Sciences, Pharmacy, or related field Fluent in English (verbal and written) Curious, self-motivating, detail-oriented, collaborative, and tech-friendly Collaborative growth-oriented mindset with the ability to work effectively with global and cross-functional teams. Hands-on experience with EDC and, preferably, CTMS systems Strong interest in clinical data workflows, data and metadata standardization, and technology-enabled trial operations Well-versed in ICH-GCP, Good Clinical Data Management Practices (GCDMP) standards, and other regulatory requirements In-depth knowledge of CDISC standards including but not limited to CDASH and SDTM (ADaM is preferrable, but not essential) Proven expertise in clinical study data management activities, including: CRF design and annotation, including univariate and multivariate edit checks eCRF and EDC form implementation (SAE Report Forms, PD Logs, etc.) Experience with data cleaning, medical coding, and database lock as well as SOP development Experience in client-facing roles with stakeholder management capabilities. Familiarity with SAE and PD workflows, including escalation procedures, tracking timelines, and documentation for audits and inspections. Experience in external vendor data integrations (central/local labs, imaging centers, IoT devices or wearables) Preferred skills: The following skills and experience areas will be considered a strong advantage for candidates: Experience working with Clinical Trial Management Systems (CTMS) and/or development is a strong asset and will be highly valued Familiarity or experience with medical coding standards (MedDRA, WHODrug) Why Join Us? You'll work with forward-thinking sponsors and a highly experienced internal team that is modernizing the way trials are conducted. This is your chance to grow in a role that bridges data, operations, and technology—while contributing to clinical research that makes a difference. Please apply with your CV via LinkedIn. Please Note: This position is being managed directly by our internal HR team. We kindly request that recruitment agencies, headhunters, and third-party staffing providers refrain from submitting candidates or inquiries for this role. Unsolicited resumes or candidate profiles submitted to any employee of Wemedoo will be considered the property of Wemedoo, and we will not be obligated to pay any fees associated with such submissions. Thank you for respecting our process.
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