Clinical Data Manager (Fully Remote)

Partner Company; United States; Remote; USD 105,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Job summary

Partner Company is seeking a skilled Clinical Data Manager to support medical device studies in the United States. You will define data elements, develop CRFs, and ensure data quality across the study lifecycle.

Collaborate with stakeholders and vendors, conduct UAT for database builds, and maintain Data Management Plans to meet GCP, ICH, GDPR, and FDA/EU regulatory requirements.

Qualifications

• Bachelor's degree in a scientific discipline with 5+ years in medical device studies.
• Knowledge of GCP, ICH, GDPR, and FDA/EU regulations.
• Strong expertise in clinical database development and validation.
• Experience collaborating with stakeholders and vendors.
• Ability to work remotely with travel as needed.

Responsibilities

• Collaborate with stakeholders to define data elements and develop CRFs.
• Liaise with database vendors and perform UAT for database builds.
• Draft and maintain Data Management Plans and ensure data quality.

Skills

GCP knowledge

ICH guidelines

GDPR knowledge

FDA/EU regulations

Clinical database development

Data quality assurance

Education

Bachelor's degree in scientific discipline

5+ years in medical device studies

Job description

• Collaborate with stakeholders to define data elements and develop CRFs.
• Liaise with database vendors and perform UAT for database builds.
• Draft and maintain Data Management Plans and ensure data quality.

Requirements:

• Bachelor's degree in a scientific discipline with 5+ years in medical device studies.
• Knowledge of GCP, ICH, GDPR, and FDA/EU regulations.
• Strong expertise in clinical database development and validation.
• Annual salary range of $105,000-$130,000.
• Comprehensive benefits including medical, dental, vision, and 401(k).
• Remote work with occasional travel and paid time off.

Partner Company

They develop innovative medical technology and manage clinical data for medical device studies. They operate in a fast-paced, collaborative environment with a focus on quality and regulatory compliance.