Lead Clinical Data Manager - Data Quality and Audits

Digital Prospectors; United States; On-site; USD 110,000 - 150,000; Full time

Job summary

Digital Prospectors is seeking an experienced Clinical Data Manager to oversee data intake, cleaning, and cross-functional coordination across clinical, medical, biometrics, and statistics teams. You will ensure data quality, listing readiness, and inspection-ready documentation for clinical studies, including investigator-sponsored trials.

The role requires 5+ years in clinical data management, strong regulatory knowledge, and experience with SAS/Python and data visualization tools like Tableau

Qualifications

• Bachelor’s degree in data sciences, health sciences, or related field.
• 5+ years of clinical data management experience in sponsor and/or CRO environments.
• Strong knowledge of GCP, FDA, ICH, and global regulatory requirements.
• Experience with laboratory data management systems such as LIMS.
• Experience with investigator-sponsored trials is a plus.
• Experience with programming or technical tools such as SAS or Python.
• Experience with data visualization tools such as Tableau or Power BI.
• Excellent written and verbal communication skills.

Responsibilities

• Oversee database validation, system testing, and documentation to ensure GCP/FDA/ICH compliance.
• Lead data intake and listing setup with Medical team and sites.
• Coordinate site data listing submissions and review cycles.
• Review and clean site data listings for completeness and protocol alignment.
• Ensure listing readiness for Biostatistics review with traceability.
• Facilitate cross-functional data review meetings and data cleaning reviews.
• Support statistical analysis and programming teams with analysis-ready datasets.
• Prepare data management documentation including listing specs and query trackers.
• Support FDA audits and regulatory submissions with audit-ready docs.
• Identify and mitigate study data risks proactively.
• Develop data insights, dashboards, and trend analyses.

Skills

Regulatory knowledge

Data management leadership

Communication skills

Cross-functional collaboration

SAS/Python programming

Education

Bachelor’s degree in data sciences, health sciences, or related field

Tools

SAS

Python

Tableau

Power BI

LIMS

Job description

Digital Prospectors is seeking an experienced Clinical Data Manager to oversee data intake, cleaning, and cross-functional coordination across clinical, medical, biometrics, and statistics teams. You will ensure data quality, listing readiness, and inspection-ready documentation for clinical studies, including investigator-sponsored trials.

The role requires 5+ years in clinical data management, strong regulatory knowledge, and experience with SAS/Python and data visualization tools like Tableau