Clinical Data Manager

Jobgether

2d • $140,000 - $155,000 • Hybrid

About The Position

This role offers the opportunity to play a pivotal part in ensuring the accuracy, reliability, and usability of clinical data within a cutting-edge medical device environment. The Clinical Data Manager will collaborate closely with both clinical operations and data science teams to manage clinical study databases, Case Report Forms (CRFs), and data quality processes for pre- and post-market studies. This position requires attention to regulatory compliance, data integrity, and process optimization, contributing directly to regulatory submissions and clinical program success. The ideal candidate thrives in a fast-paced, dynamic environment, demonstrates strong analytical and problem-solving skills, and is adept at coordinating multiple stakeholders to achieve high-quality, timely outcomes. The role combines technical expertise with leadership and collaboration, providing significant impact on the advancement of innovative medical technologies.

Requirements

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• Minimum of 5 years’ experience in medical device clinical studies.
• Knowledge of GCP, ICH, GDPR, FDA, and EU regulatory requirements.
• Familiarity with CDM standards for medical devices; pre-market experience preferred.
• Expertise in CRF development, database design, validation, discrepancy management, and final database archival.
• Strong analytical, critical thinking, and problem-solving skills.
• Excellent written and verbal communication skills, with proven ability to collaborate across teams.
• Ability to prioritize tasks, meet deadlines, and manage shifting priorities in a fast-paced environment.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
• Willingness to travel up to 10% of the time and ability to lift 20lbs.

Nice To Haves

• Experience as CRA or in clinical systems administration/data analysis is a plus.

Responsibilities

• Collaborate with stakeholders to ensure all relevant data elements are captured during CRF development.
• Develop and manage CRFs for clinical studies, both pre- and post-market.
• Serve as a liaison with database vendors, ensuring proper database design, CRF implementation, and specifications compliance.
• Perform User Acceptance Testing (UAT) on new or updated databases, standardizing testing methods and providing vendor feedback.
• Draft Data Management Plans (DMPs) and Data Review Plans for all studies.
• Ensure data quality through pre-specified and ongoing queries, discrepancy management, and timely data locks for reporting and regulatory submissions.
• Support statistical analyses and develop clinical metrics for internal and external purposes.
• Assist in internal and external audits as needed, maintaining regulatory and data compliance.

Benefits

• Competitive salary range: $140,000 - $155,000 USD/year.
• Health, dental, and vision insurance coverage.
• Life insurance, short-term and long-term disability.
• 401(k) retirement plan.
• Paid time off and company holidays.
• Opportunity for hybrid work in Plymouth, MN with flexible collaboration across teams.
• Professional growth and exposure to innovative medical technologies.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level