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Compliance Specialist

Company: Medpace Inc
Location: Cincinnati
Posted on: September 17, 2021

Job Description:

An employer is seeking a Compliance Specialist for a direct-hire opportunity in the Cincinnati, OH area. The client is an industry leading Clinical Research Organization, and the Compliance Specialist will work with various departments within the organization to coordinate validation projects, and ensure those tests are properly executed.

This includes, but is not limited to:

Facilitating and supporting internal business users to validate regulated third-party software applications (including, but not limited to, instrument software and custom calculation spreadsheets) according to client SOPs;

Assist business users in defining user requirements and configuration specifications for regulated activity performed in third-party software applications;

Develop and facilitate the execution of acceptance test scripts for third-party software applications;

Write Validation Plans and Summary Reports for validation projects conducted for third-party software applications;

Proactively maintain in-depth knowledge of regulatory requirements and manage 21 CFR Part 11 Compliance Assessments for each regulated third-party software application;

Coordinate with vendors and/or service providers contracted to perform validation activities to ensure compliance with client SOPs and regulatory guidance;

Provide guidance as needed to ongoing risk assessments and/or ensuring procedural controls are in place to mitigate risk and maintain compliance;

Conduct internal reviews of validation projects for both third-party and custom systems to ensure compliance with client SOPs and regulatory guidance;

Assist in gathering evidence during sponsor audits and regulatory inspections.

Knowledge of GCP (Good Clinical Practice), GLP (Good Laboratory Practice), 21 CFR Part 11, SOX, GDPR, or any other government compliance

CRO/clinical/healthcare industry experience, or experience within another highly regulated industry (finance, banking, etc.)
Bachelors Degree, preferred in computer-related background but not absolutely necessary

1+ year manual software testing/system validation experience

Proven project coordination/project management skills

Excellent communication skills both written and oral

Stable job history (tenure of 3+ years in each prior role, especially if number of experience exceeds 3 years)

Undergrad GPA of 3.0 or higher

Keywords: Medpace Inc, Cincinnati , Compliance Specialist, Other , Cincinnati, Ohio

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