Clinical Data Manager

This range is provided by SPECTRAFORCE. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$42.00/hr - $45.00/hr

Position Title: Clinical Data Manager

Work Location: Maple Grove, MN 55311

Assignment Duration: 6 months (potential to extend highly likely)

• The Clinical Data Manager is responsible for managing the development, documentation, and execution of risk-based quality management systems, as described in the risk assessment, data management plan, and site and central monitoring plans.
• As the customer-facing component of Data Review and its primary liaison with the therapy group, the Clinical Data Manager’s therapy-specific knowledge ensures alignment to customer definitions of criticality, and informs review and analysis of study data.

• Oversee 3-5 clinical trials from a data management perspective, and together with an assigned Coordinator, manage all related activities from CRF design, clinical data review and oversight, to trial closure related data activities.
• Identify study-specific risks to study conduct and human subject safety; analyze risks; develop and implement mitigation strategies.
• Review study data to detect anticipated and unanticipated issues related to trial data completeness and quality.
• Facilitate multi-stakeholder discussions to review findings, evaluate impact and develop action plans for correction and continued monitoring.
• Conduct Central Monitoring activities, as described in the Central Monitoring Plan.
• Direct all data cleaning activity related to assigned studies.

• Bachelor’s Degree in Biology, Health Sciences, Mathematics, Computer Science, or equivalent.

Minimum 3 years

• 3 years in clinical operations or a healthcare-related field.
• Analytical and critical thinking skills with experience in data management/analysis (not statistical analysis).
• Education and work experience in project management, life sciences and/or technical field.
• Knowledge of data collection best practices for clinical trials.
• Knowledge of global clinical operations.
• Experience in a consultative role, with subject matter expertise, effectively influencing team decisions to desired outcomes.
• Proficient at risk identification, evaluation of likelihood and impact, and development of effective mitigation and monitoring strategies.
• Proficient in translating clinical trial requirements to technical specifications required for effective data collection.
• Skilled at making inferences and connections based on limited information, clearly describing the knowns, unknowns, and alternative explanations.
• Intermediate project management skills; developing a multifaceted plan with complex dependencies and holding peers accountable to adherence to the plan while maintaining positive and collaborative relationships.
• Intermediate therapy-specific knowledge of anatomy, physiology, pathophysiology, therapy and device.

• None required;
  Certified Clinical Data Manager (CCDM) or equivalent is nice to have.

Associate

Contract

Science

Pharmaceutical Manufacturing