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clinical data manager

title: Key Responsibilities and Required Skills for Clinical Data Manager
salary: $ - $
categories: ["Clinical Data Management", "Clinical Trials", "Healthcare", "Pharmaceuticals"]
description: A comprehensive overview of the key responsibilities, required technical skills and professional background for the role of a Clinical Data Manager.
Detailed, recruiter-style overview of the Clinical Data Manager role: responsibilities, career progression,
and required technical and soft skills optimized for search (clinical data manager, EDC, CDISC, SDTM,
MedDRA, ICH-GCP, database lock, data cleaning, query management). Useful for job postings, SEO and LLM-based
parsing to attract qualified clinical data management candidates for sponsor and CRO roles.

🎯 Role Definition

The Clinical Data Manager (CDM) is responsible for the design, implementation, validation and maintenance of clinical trial databases and associated processes to ensure clean, accurate, and regulatory-compliant clinical data for statistical analysis and regulatory submission. The CDM leads the development of data management plans (DMP), CRF/eCRF design, edit checks and validation rules in Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical, OpenClinica), coordinates query resolution and data reconciliation activities (IVRS/IWRS, central labs, ePRO), oversees coding (MedDRA, WHODrug) and SAE processing, and partners with clinical operations, biostatistics, programming and regulatory affairs to deliver locked, submission-ready datasets (CDISC SDTM/ADaM) on schedule and in compliance with ICH-GCP and applicable regulatory requirements (FDA, EMA).

📈 Career Progression

Typical Career Path

Entry Point From:

  • Clinical Research Coordinator (CRC) or Clinical Trial Assistant (CTA)
  • Data Analyst or SAS/SQL Programmer with clinical experience
  • Clinical Operations Associate or Clinical Research Associate (CRA)

Advancement To:

  • Senior Clinical Data Manager
  • Lead Data Manager / Data Management Team Lead
  • Clinical Data Management Director or Head of Data Management

Lateral Moves:

  • Clinical Project Manager (CPM)
  • Biostatistician or Clinical SAS Programmer
  • Regulatory Affairs or Pharmacovigilance roles

Core Responsibilities

Primary Functions

  • Lead the end-to-end design, build and validation of study databases and eCRFs in the selected EDC system, ensuring CRF completeness, logical flow and alignment with the protocol, source documents and statistical analysis plan.
  • Develop, author and maintain the Data Management Plan (DMP), Data Handling Specifications, CRF Completion Guidelines and other study-specific data management documentation in accordance with SOPs and regulatory expectations.
  • Define, write and test edit checks, data validation rules, derived fields and complex programmed checks in the EDC to enforce data quality and support efficient query management.
  • Manage database build timelines and vendor relationships during database configuration, unit testing, system/integration testing and user acceptance testing (UAT); coordinate change control and track deviations.
  • Execute study start-up tasks for data management including study configuration, user roles and permissions, user acceptance testing coordination, and readiness for data capture at first subject first visit (FSFV).
  • Oversee ongoing data cleaning activities: monitor data entry metrics, prioritize and manage data queries, lead query reconciliation and closure with sites, and work cross-functionally to resolve data discrepancies.
  • Plan and perform data reconciliations between eCRF and external systems (IVRS/IWRS, central labs, imaging vendors, ePRO, central monitoring systems) and document reconciliation processes and outcomes.
  • Coordinate SAE/AEs and safety data handling processes, ensure timely escalation, coding to MedDRA and WHODrug as required, and reconciliation with pharmacovigilance and safety databases.
  • Prepare and deliver database freeze/lock activities: run pre-lock reconciliations, finalize outstanding queries, validate dataset derivations, document sign-off packages and facilitate database lock in partnership with biostatistics.
  • Implement and enforce CDISC standards (SDTM/ADaM) and CDASH mappings; liaise with programming and statistical teams to ensure datasets and metadata are specification-compliant and submission-ready.
  • Produce and review key deliverables such as data listings, discrepancy reports, edit check logs, data transfer specifications, and dataset specifications to support interim reviews and statistical analysis.
  • Manage and mentor junior data management staff and CRO data teams; assign work, provide training on EDC, edit-check logic and SOPs, and review their work for quality and compliance.
  • Participate in protocol and CRF review meetings, providing data feasibility input to study design, data collection burden, critical data elements and potential sources of missing or inconsistent data.
  • Maintain and update trial master file (TMF) and eTMF entries related to data management deliverables; ensure documentation completeness for inspections and audits.
  • Support data migrations, controlled datasets transfers and vendor deliverables (lab data, imaging, wearable device data), including mapping, validation checks and reconciliation.
  • Support regulatory inspection readiness: prepare data management sections of inspection packages, respond to regulatory requests, and provide input during sponsor or site audits.
  • Collaborate closely with biostatistics, clinical programmers (SAS/R), safety teams and external vendors to ensure traceability from raw eCRF data to analysis datasets and tables/figures.
  • Create and maintain data dictionaries, CRF-to-dataset mapping and define derivation rules and derived variables that will be used in analysis datasets.
  • Monitor and report data quality metrics and KPIs (query rates, query turnaround, eCRF completion rates) to project teams; propose and implement corrective actions or process improvements.
  • Lead, participate in or support study close-out activities for data management: ensure final reconciliation, archive datasets and documentation, and deliver final data packages to sponsors and statistical teams.
  • Ensure compliance with applicable regulations including ICH-GCP, 21 CFR Part 11 (when applicable), GDPR/data privacy and company SOPs for data handling and security.
  • Review vendor contracts and oversee CRO/vendor performed data management activities to ensure SLAs and quality standards are met; escalate vendor performance issues as needed.
  • Draft and review data transfer agreements, data extraction specifications and technical documentation for external data submissions and cross-system integrations.
  • Evaluate new EDC or data management tools and participate in system selection, validation and SOP updates to improve efficiency and data quality.

Secondary Functions

  • Support ad-hoc data requests and exploratory data analysis.
  • Contribute to the organization's data strategy and roadmap.
  • Collaborate with business units to translate data needs into engineering requirements.
  • Participate in sprint planning and agile ceremonies within the data engineering team.

Required Skills & Competencies

Hard Skills (Technical)

  • Expertise with Electronic Data Capture (EDC) systems such as Medidata Rave, Oracle Clinical, Veeva, OpenClinica, or ClinCapture including CRF design, edit-check programming and system testing.
  • Strong understanding of CDISC standards (CDASH, SDTM and ADaM) and experience mapping CRF data to SDTM/ADaM datasets.
  • Experience with AE/Medication coding using MedDRA and WHODrug (or the ability to oversee vendor coding processes).
  • Proficiency with data validation, edit-check logic, discrepancy management and query lifecycle tools and processes.
  • Working knowledge of statistical programming concepts and tools (SAS, R) and experience producing data deliverables for statisticians.
  • Familiarity with database validation, system qualification, data migration, controlled data transfers and 21 CFR Part 11 compliance requirements.
  • Ability to author and maintain key data management documents: DMP, CRF completion guidelines, validation plans, data transfer specifications and dataset specifications.
  • Experience with SQL (querying clinical databases), data reconciliation techniques and working with external data sources (labs, imaging, ePRO, IVRS/IWRS).
  • Knowledge of ICH-GCP, regulatory submission expectations (FDA/EMA) and clinical trial lifecycle requirements.
  • Proficiency in using tracking and project tools (JIRA, Confluence, CTMS) and MS Office suite (Excel pivot tables, Word, PowerPoint) for reporting and documentation.

Soft Skills

  • Excellent oral and written communication skills for cross-functional collaboration with clinical operations, programming, safety and regulatory teams.
  • Strong attention to detail and high standards for data quality and documentation.
  • Analytical problem-solving skills with ability to prioritize and troubleshoot complex data issues under tight timelines.
  • Project and time-management skills to manage multiple studies, deliverables and vendor relationships concurrently.
  • Leadership and mentorship skills to coach junior staff and manage outsourced data management activities.
  • Stakeholder management and negotiation skills to align clinical, statistical and vendor priorities.
  • Adaptability and continuous improvement mindset to recommend and implement process and tooling enhancements.
  • Customer-service orientation with a collaborative, team-driven approach.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, Statistics, Biostatistics, Computer Science, Information Systems or related field.

Preferred Education:

  • Master's degree in Clinical Research, Public Health, Biostatistics, Data Science or related discipline.
  • Certifications such as CDISC training, SoCRA/ACRP certification, or SAS certification are advantageous.

Relevant Fields of Study:

  • Clinical Research / Clinical Data Management
  • Life Sciences (Biology, Pharmacy, Nursing)
  • Statistics / Biostatistics / Data Science
  • Computer Science / Information Systems

Experience Requirements

Typical Experience Range:

  • 3–7 years of progressive clinical data management experience for sponsor or CRO roles, including hands-on experience with EDC systems and data cleaning.

Preferred:

  • 5+ years in clinical data management with experience in CDISC implementation (SDTM/ADaM), database lock processes, vendor oversight and submission-ready dataset delivery.
  • Experience within therapeutic areas such as oncology, CNS, cardiology or rare disease is a plus, as is prior experience supporting regulatory submissions and inspections.
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