Hybrid Location: Hybrid (Minimum 3 Days Onsite Per Week) Job Type: Contract
Advance Clinical Research Through Data Excellence
We are seeking an experienced Clinical Data Manager II to join a high-performing clinical research team supporting innovative clinical trials. This hybrid contract opportunity is ideal for a data-driven professional who thrives at the intersection of clinical data management, technology, and process improvement. In this role, you will oversee clinical trial data from collection through validation, ensuring data quality, regulatory compliance, and operational efficiency. Beyond traditional data management responsibilities, you will leverage Python programming and workflow automation tools to optimize data processes, enhance reporting capabilities, and support study teams across multiple functions.
Key Responsibilities
- Manage data collection, cleaning, review, and validation activities across assigned clinical studies.
- Ensure the accuracy, completeness, and integrity of clinical trial data throughout the study lifecycle.
- Support the design, build, testing, and implementation of Electronic Data Capture (EDC) systems.
- Participate in User Acceptance Testing (UAT) and development of data validation specifications.
- Lead data query generation, reconciliation, tracking, and resolution activities in collaboration with investigative sites and CRO partners.
- Database Development & Automation: develop and execute Python-based automation tools and scripts for data extraction, validation, cleaning checks, and metrics reporting.
- Identify opportunities to streamline data management workflows through technology and process improvements.
- Evaluate existing data infrastructure and implement solutions that improve data quality, efficiency, and scalability.
- Collaborate with Biostatistics and technical teams to support data standardization and transformation efforts, including CDISC SDTM and CDASH requirements.
- Compliance & Cross-Functional Collaboration – ensure all clinical data management activities comply with Good Clinical Practice (GCP), ICH Guidelines, FDA regulations, 21 CFR Part 11, and internal SOPs; prepare and maintain documentation required for audits, inspections, and regulatory submissions; partner with Clinical Operations, Quality Assurance, Biostatistics, and Site Management teams to meet project timelines and study milestones.
Qualifications
- Education – Bachelor's degree in Life Sciences, Computer Science, Health Informatics, Data Science, or a related field.
- Master's degree preferred.
- Experience – Minimum 2+ years of clinical data management experience supporting clinical trials.
- 0 to 5 years of overall professional experience.
- Technical Skills – Advanced experience with Python for automation, data processing, and system integration.
- Familiarity with SQL, R, or SAS is highly desirable.
- Hands-on experience with leading EDC platforms such as: Medidata Rave, Veeva Vault CDMS, REDCap, Oracle InForm.
- Strong understanding of data standards, regulatory requirements, and audit readiness.
What Makes You Successful
- Self-motivated with a demonstrated ability to take ownership and drive projects independently.
- Strong analytical and problem-solving skills with exceptional attention to detail.
- Ability to manage complex datasets in a fast-paced clinical research environment.
- Excellent communication skills, with the ability to explain technical concepts to both technical and non-technical stakeholders.
- Collaborative mindset with proven success working across cross-functional clinical development teams.