Clinical Data Manager

20 hours ago

Saint Paul, Minnesota, United States Select Source International Full time

Job Title – Clinical Data Manager
Job Location Type – Hybrid (4 days/week onsite)
Location – St. Paul, MN 55117
Job Type – Contract|
Duration – 6 Months
Shift Schedule – 8:00 AM – 5:00 PM CST
Overview -
The Clinical Data Manager is responsible for developing, documenting, and executing risk-based quality management systems to ensure high-quality clinical trial data and the protection of human subjects. This role serves as the primary liaison between Data Review and therapy groups, applying therapy-specific expertise to align data review and central monitoring activities with study requirements and customer definitions of criticality.

Responsibilities -

  • Identify study-specific risks to study conduct, data integrity, and subject safety; assess likelihood and impact and implement effective mitigation and monitoring strategies.
  • Review clinical trial data to identify anticipated and unanticipated issues related to data completeness, quality, and data trends.
  • Conduct Central Monitoring activities in accordance with the Central Monitoring Plan.
  • Lead data review, data cleaning, and central monitoring activities for assigned studies.
  • Facilitate cross-functional and multi-stakeholder discussions to review findings, assess impact, and develop corrective and preventive action (CAPA) plans.
  • Serve as the primary customer-facing representative for Data Review and the primary liaison with therapy groups.
  • Translate clinical trial requirements into technical specifications to ensure effective and compliant data collection.
  • Ensure alignment across Risk Assessment, Data Management Plan (DMP), Site Monitoring Plan (SMP), and Central Monitoring Plan (CMP).
  • Apply therapy-specific knowledge to inform data review, analysis, and decision-making.
  • Proactively identify risks and trends that may impact study conduct or data integrity.

Qualifications & Requirements -
Must-Have -

  • Minimum of 3 years of experience in clinical operations or a healthcare-related field.
  • Education and/or professional experience in life sciences, project management, or a technical discipline.
  • Knowledge of clinical trial data collection best practices and global clinical operations.
  • Experience working in a consultative or subject matter expert capacity with the ability to influence decisions.
  • Strong risk assessment and mitigation skills, including evaluating likelihood, impact, and monitoring effectiveness.
  • Strong analytical skills with the ability to interpret limited data and clearly communicate insights and recommendations.
  • Intermediate project management skills, including managing complex dependencies and maintaining accountability across teams.
  • Intermediate therapy-specific knowledge (anatomy, physiology, pathophysiology, therapy, and/or medical devices).

Preferred -

  • Certified Clinical Data Manager (CCDM) or equivalent certification.

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