Manager, EDC

Job Summary:

This position is responsible for configuring, managing, and supporting clinical research teams in data entry and validation, and ensuring adherence to regulatory and sponsor requirements. The EDC Manager will work closely with the site staff to optimize electronic data workflows and maintain data integrity.

Duties/Responsibilities:

• Support clinical research site staff with accurate data entry, query resolution, and validation checks to ensure data quality.
• Ensure data management processes adhere to Good Clinical Practice (GCP), FDA, and sponsor-specific regulations.
• Monitor data discrepancies, perform data cleaning activities
• Work closely with clinical research teams, sponsors, and IT teams to optimize data collection, reporting, and security.
• Identify and resolve EDC system issues, escalating as necessary to vendors or IT teams.
• Other duties as assigned

Required Skills/Abilities:

• Strong understanding of clinical trial data collection, GCP guidelines, and regulatory requirements.
• Excellent analytical skills and attention to detail to ensure data accuracy and compliance.
• Ability to work independently and collaboratively in a fast-paced clinical research setting.

Education and Experience:

• High School Graduate and/or technical degree required
• Bachelor’s degree or Associate’s degree preferred
• Minimum of four (4) to six (6) years of clinical research experience preferred
• Two (2) to three (3) years previous supervisory experience preferred

NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the company, the department, and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.