Clinical Data Manager II

November 6, 2026
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Job Description

Job Summary:

  • We are seeking a highly technical, proactive, and driven Clinical Data Manager II to join our data management team.
  • In this role, you will oversee end-to-end data collection and validation processes, design robust clinical databases, and maintain compliance across all clinical trials.
  • Beyond core data management capabilities, the ideal candidate brings strong technical expertise in Python scripting and automated software tools to modernize clinical data workflows.
  • You are a self-starter who takes the initiative to solve complex data challenges, streamlines query resolution, and collaborates seamlessly across cross-functional study teams.

Duties & Responsibilities:

  • Data Management & Database Development Oversee data collection, cleaning, and validation activities across assigned clinical trials to ensure high data quality, accuracy, and completeness.
  • Participate in the design, development, and testing of Electronic Data Capture (EDC) systems, user acceptance testing (UAT), and data validation specifications.
  • Manage query generation, reconciliation, and resolution workflows, working closely with clinical trial sites and CRO partners.
  • Technical Scripting & Workflow Automation Develop and execute custom Python scripts and software utilities to automate data extraction, validation, routine cleaning checks, and metrics reporting.
  • Evaluate trial data infrastructure to identify technical bottlenecks, implementing software solutions that enhance processing speed and data accuracy.
  • Partner with technical and biostatistics teams to streamline data transformations and standardizations (e.g., CDISC SDTM/CDASH).
  • Compliance, Audits & Cross-Functional Collaboration Ensure all clinical data management activities strictly adhere to Good Clinical Practice (GCP), ICH guidelines, FDA regulations, and standard operating procedures (SOPs).
  • Prepare, maintain, and review clinical data management documentation for regulatory inspections and quality audits.
  • Collaborate cross-functionally with Clinical Operations, Biostatistics, Quality Assurance, and Site Management teams to achieve trial milestones on schedule.

Required Qualifications:

  • Experience & Education Education: Bachelor’s Degree in Life Sciences, Computer Science, Health Informatics, Data Science, or a related field. Master’s degree is a plus.
  • Professional Experience: Minimum of 2+ years of clinical data management experience within clinical trials (0–5 years total professional experience).

Technical Competencies Technical Scripting:

  • Advanced hands-on proficiency in Python for script automation, data manipulation, and software integration. Familiarity with additional programming languages (e.g., SQL, R, or SAS) is strongly desired.
  • EDC Systems: Practical experience working with industry-leading EDC platforms (e.g., Medidata Rave, Veeva Vault CDMS, RedCap, or Oracle InForm).
  • Regulatory Knowledge: Solid understanding of GCP standards, 21 CFR Part 11, and regulatory audit readiness expectations.

Soft Skills & Core Attributes Initiative & Drive:

  • Self-motivated mindset with a strong track record of taking ownership of projects and driving results independently.

Problem-Solving:

  • Strong analytical capabilities with meticulous attention to detail in high-volume, complex data environments.

Collaboration & Communication:

  • Excellent written and verbal communication skills; ability to articulate technical data solutions clearly to non-technical stakeholders.