Clinical Data Manager

Position Summary The Clinical Data Manager (CDM) is responsible for the end-to-end management, quality control, and analysis of clinical cohort data. This role ensures data integrity, identifies and resolves irregularities, and partners closely with laboratory operations and bioinformatics engineering to enable high-quality and timely data delivery. The CDM will play a critical role in supporting clinical data pipelines, investigating anomalies, and driving MRD-focused analyses, pipeline improvements, and research initiatives.

Clinical Data Management & QC

• Manage and track clinical cohorts, ensuring accurate sample metadata and traceability
• Perform QC review, validation checks, and deviation logging across datasets
• Identify and investigate irregularities (e.g., contamination, sample swaps, unexpected results)
• Ensure reproducibility, traceability, and audit readiness of clinical datasets

Data Investigation & Pipeline Interaction

• Investigate abnormalities using statistical and bioinformatics approaches
• Run and monitor pipelines for data reprocessing and corrections
• Interface with bioinformatics pipelines via command line and scripting
• Troubleshoot data issues end-to-end from raw data through final outputs

Cross-Functional Collaboration

• Act as liaison between Lab Operations and Bioinformatics Engineering
• Ensure rapid resolution of data issues and timely delivery
• Communicate findings clearly and escalate issues when necessary

Data Systems & Reporting

• Interact with internal databases and correct inconsistencies
• Develop dashboards to monitor cohort progress, QC metrics, and delivery timelines
• Generate reports summarizing data quality, deviations, and investigations

Advanced Analysis & Research Support

• Perform in-depth analysis on unblinded clinical datasets
• Identify biological signals, artifacts, and noise sources (especially in MRD contexts)
• Drive improvements to pipelines and QC heuristics based on data insights
• Support development of new assays and analytical approaches
• Contribute to publications, internal reports, and regulatory documentation

Regulatory & External Collaboration

• Support documentation for regulatory submissions and audit readiness
• Prepare clinical datasets for collaborators
• Manage data transfer, submission, and tracking across studies

Requirements Required Qualifications & Skills

• PhD in Bioinformatics, Computational Biology, Statistics, or related field
• 3?7+ years of experience in clinical data management or clinical genomics
• Strong experience with NGS data, including MRD (minimal residual disease) analysis
• Proficiency in Python (pandas or similar for data analysis)
• Experience with SQL or database systems
• Familiarity with Linux/Unix and command-line tools
• Strong statistical and analytical skills
• Ability to work cross-functionally in a fast-paced environment

Preferred

• Experience with tumor-normal and cfDNA workflows
• Experience building dashboards or tracking tools
• Knowledge of GCP and regulatory processes
• Experience supporting submissions and publications