Clinical Data Manager

Meditrial; Minnesota; On-site; USD 85,000 - 110,000; Full time

Job summary

Medictrial is seeking a Clinical Data Manager to oversee data management for medical device trials. This office-based role in Minneapolis involves ensuring data integrity, regulatory compliance, and timely delivery throughout study phases.

The ideal candidate will have a solid background in clinical data management, particularly in medical devices, alongside strong communication skills to interface with cross-functional teams.

Qualifications

• 5 years of clinical data management experience, with at least 2 years in medical devices.
• Hands-on proficiency with one or more EDC/CDMS platforms.
• Solid working knowledge of FDA 21 CFR Part 11, ISO 14155, and ICH GCP E6(R2).

Responsibilities

• Lead end-to-end clinical data management for medical device studies.
• Design, build, and validate eCRFs and clinical databases.
• Develop and maintain key data management documents.

Skills

Clinical data management

Proficiency with EDC/CDMS platforms

Knowledge of FDA 21 CFR Part 11

Attention to detail

Communication skills

Education

Bachelor's degree in life sciences

Master's degree (a plus)

Tools

Medidata Rave

Oracle InForm

Veeva Vault

Job description

We're looking for a skilled and detail-oriented Clinical Data Manager to join our medical device trials team. You\'ll own the full data management lifecycle across Phase I–IV studies, ensuring data integrity, regulatory compliance, and on-time delivery. This is a high-impact role for someone who thrives in a fast-paced, multi-project environment and takes pride in clean, audit-ready data. The position is office based in Minneapolis.

Responsibilities

• Lead end-to-end clinical data management activities for medical device studies across multiple therapeutic areas and all trial phases (I–IV)
• Design, build, and validate eCRFs and clinical databases using industry-standard EDC platforms (Medidata Rave, Oracle InForm, Veeva Vault, or similar)
• Develop and maintain key data management documents including DMPs, DVPs, edit check specifications, and data transfer agreements
• Perform ongoing data review, query management, and SAE reconciliation to ensure timely, high-quality data
• Collaborate with biostatistics, clinical operations, regulatory affairs, and medical monitors throughout the trial lifecycle
• Ensure all data management activities comply with FDA 21 CFR Part 11, ISO 14155, ICH E6(R2) GCP, MDR and applicable regulatory frameworks
• Support internal and sponsor audits; maintain inspection-ready TMF documentation
• Contribute to process improvement initiatives and SOP development

Qualifications & Personal Skills

• 5 years of clinical data management experience, with at least 2 years in medical devices
• Hands-on proficiency with one or more EDC/CDMS platforms (Medidata Rave, Oracle InForm, Veeva Vault, or equivalent)
• Solid working knowledge of FDA 21 CFR Part 11, ISO 14155, and ICH GCP E6(R2)
• Experience managing data across multiple concurrent studies and therapeutic areas
• Strong understanding of CDISC standards (CDASH, SDTM) is a plus
• Exceptional attention to detail and a systematic approach to problem-solving
• Excellent written and verbal communication skills; comfortable interfacing with sponsors and cross-functional teams
• Bachelor\'s degree in a life sciences, health informatics, or related field (Master\'s a plus)