Clinical Data Manager, Medical Devices (Contract)

Mindlance; Maple Grove (MN); On-site; USD 69,000 - 103,000; Part time

Job summary

Mindlance is seeking a detail-oriented Clinical Data Manager to support medical device clinical investigations and studies. You will collect, review, validate, clean, and maintain study data to ensure accuracy, completeness, and regulatory compliance.

You will collaborate with CRAs, CRCs, Clinical Operations, Biostatistics, QA, and Regulatory Affairs to ensure timelines and data integrity across the study lifecycle.

Qualifications

• Bachelor's or Master's degree in Life Sciences or related field.
• 0–3 years of experience in clinical data management, clinical research, clinical operations, or related area.
• Familiarity with electronic data capture (EDC) systems and electronic Case Report Forms (eCRFs).
• Basic knowledge of clinical data review, query management, and data validation.
• Proficiency in Microsoft Excel and other Microsoft Office applications.

Responsibilities

• Support clinical data management activities for medical device clinical trials and investigations.
• Assist in developing and maintaining electronic Case Report Forms (eCRFs) and data collection tools.
• Perform clinical data review, validation, discrepancy identification, and data cleaning.
• Generate, review, and resolve data queries in coordination with clinical study sites and study teams.
• Ensure clinical data is accurate, complete, consistent, and collected in accordance with study protocols.
• Support the development and execution of data validation checks and edit checks.
• Maintain clinical databases and ensure timely data entry, reconciliation, and database updates.
• Assist with medical coding activities, including adverse events and medical history, where applicable.
• Support reconciliation of clinical data with safety databases and other study records, as required.
• Maintain data management plans, data validation specifications, query logs, and other study documentation.
• Support database lock activities and preparation of clinical study reports.
• Ensure compliance with applicable regulatory requirements, Good Clinical Practice (GCP), data privacy requirements, and company SOPs.
• Participate in clinical study audits, inspections, and quality improvement activities as required.
• Collaborate with cross-functional teams to resolve data discrepancies and maintain study timelines.

Skills

Attention to detail

Analytical thinking

Cross-functional collaboration

Communication skills

Problem solving

Education

Bachelor's degree in Life Sciences or related field

Master's degree (preferred)

Tools

EDC systems

eCRF familiarity

Medidata Rave

Oracle Clinical

REDCap

Job description

Mindlance is seeking a detail-oriented Clinical Data Manager to support medical device clinical investigations and studies. You will collect, review, validate, clean, and maintain study data to ensure accuracy, completeness, and regulatory compliance.

You will collaborate with CRAs, CRCs, Clinical Operations, Biostatistics, QA, and Regulatory Affairs to ensure timelines and data integrity across the study lifecycle.