Clinical Data Manager II

Position 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.

Primary 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.

Qualifications & Key Requirements

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.