Clinical Data Manager – Full Time Contractor

This is a fully remote position, open to applicants in United States.

📋 Description

• Create and uphold Data Management Plans (DMPs), data validation specifications, data review plans, and associated study documentation.

• Evaluate eCRFs, edit checks, database specifications, and EDC functionality to ensure they are suitably designed and aligned with study requirements.

• Perform continuous data reviews, pinpoint discrepancies and trends, and manage data queries through resolution to guarantee timely and thorough data cleaning.

• Reconcile EDC data with external data sources, which include central laboratory, imaging, ECG, PK/PD, eCOA, IRT/RTSM, and safety data.

• Assist in SAE reconciliation, user acceptance testing (UAT), interim analyses, and database lock activities, ensuring that all tasks adhere to timelines and quality standards.

• Oversee data transfers and manage CRO and vendor deliverables, proactively identifying and resolving data quality, timeline, and operational risks.

• Ensure adherence to applicable regulations, SOPs, study procedures, and CDISC/CDASH standards throughout all data management activities.

• Collaborate with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety, Regulatory, CROs, and vendors to facilitate seamless cross-functional data execution.

• Contribute to enhancing data review, cleaning, reconciliation, and database lock processes; assist in SOP development and process documentation as necessary.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Computer Science, Data Management, or a related discipline.

• Over 5 years of clinical data management experience in biotechnology or pharmaceutical development, including support for studies through database lock.

• Proficient in Medidata Rave, Veeva Vault CDMS, or similar EDC systems.

• Experience with external data reconciliation, data transfers, edit check specifications, validation specifications, and database documentation.

• Strong understanding of clinical data standards and regulations, including CDISC/CDASH, ICH-GCP, and risk-based data management principles.

• Experience in managing CRO and technology vendors in a data management role.

• Excellent analytical, organizational, communication, and problem-solving abilities.

• Capability to work independently and juggle competing priorities in a fast-paced biotech setting.

• Preferred: Experience in oncology, early-phase, or first-in-human clinical studies.

• Preferred: Familiarity with IRT/RTSM, central laboratory, imaging, PK/PD, eCOA, ECG, or safety data streams.

• Preferred: Knowledge of data review tools, dashboards, automated checks, or AI-enabled data review platforms.

• Preferred: Experience in building and refining data management processes within a small-to-mid-size biotech environment.

🏝️ Benefits

• Initial contract engagement with the possibility of transitioning to a full-time employee (FTE) role based on performance and organizational needs.

• Estimated weekly utilization of 40 hours per week.