Clinical Data Manager II

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.

• 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.

• 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).

• 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:

• 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 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.

• 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.

Divya

divya@itengagments.com