Clinical Data Manager

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

Please no agencies. Direct employees currently authorized to work in the United States - no sponsorship available

Job Description

A clinical development team is seeking an experienced Clinical Data Manager to oversee data intake, review, cleaning, documentation, and cross-functional coordination across clinical, medical, biometrics, and statistics teams. This role will support data quality, listing readiness, audit preparedness, and inspection-ready documentation across clinical studies, including investigator-sponsored trials.

Essential Duties and Responsibilities

• Oversee database validation, system testing, and documentation to ensure compliance with GCP, FDA, ICH, and internal SOPs.
• Lead data intake and listing setup in partnership with the Medical team and investigative sites, including standardized listing templates, data specifications, transfer schedules, review rules, and quality-control requirements.
• Serve as the lead data management contact for investigator-sponsored trials, working directly with the Medical team and investigative sites to coordinate site data listing submissions, review cycles, and issue resolution.
• Lead the review and cleaning of site-provided clinical data listings for completeness, consistency, accuracy, and protocol alignment; issue and track data queries with sites through documented resolution.
• Own listing readiness for Biostatistics review by reconciling relevant data sources, confirming all critical queries are resolved, and delivering clean, quality-controlled, and version-controlled clinical data listings with clear traceability.
• Administer data review responsibilities across clinical, medical, and biometrics teams. Facilitate cross-functional data review meetings and data cleaning reviews.
• Support statistical analysis and programming teams by ensuring high-quality, analysis-ready datasets.
• Prepare and maintain data management and review documentation, including listing specifications, site data submission guidance, data review plans, query trackers, decision logs, and quality-control evidence.
• Support FDA audits, regulatory inspections, and submission activities, and ensure inspection readiness and audit-compliant documentation.
• Identify and mitigate study data risks proactively.
• Develop innovative data insights and tools to enhance data visualization, reporting, and analysis. Create and maintain metrics dashboards and trend analyses.
• Contribute to departmental process improvements and SOP development.
• Lead weekly stand-ups and cross-functional data review meetings.
• Provide training and guidance to the Medical team and investigative sites on listing templates, data conventions, submission timelines, quality expectations, and query resolution processes.

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 managing data for investigator-sponsored trials is a plus.
• Experience with laboratory sample and data management systems such as LIMS.
• Experience with international and multicenter trials.
• Experience across multiple oncology indications.
• Experience with lab sample data reconciliation and database lock processes.
• Strong project management and vendor oversight skills.
• Experience with programming or technical tools such as SAS or Python.
• Experience with data visualization tools such as Tableau or Power BI.
• Experience preparing documentation for regulatory submissions and audits.
• Excellent written and verbal communication skills.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.