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a rich 25-year history of being the author, scaler, and leader of integrated payments. Today our business serves over one thousand software companies and over 700K of their end-software users with their payment solutions. The needs of these end-users...
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CBTSCincinnati
Assets, Cost Center Accounting, Profit Center Accounting, and Internal Orders.
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Clinical Compliance Business Analyst - IT Systems
Cincinnati | careers.medpace.com |
Job Summary:
Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Compliance Business Analyst to join our System Validation team. The BA will work with internal business users in other Medpace departments to validate third-party software applications.
These applications include, but are not limited to, analytical instrument software and custom calculation Excel spreadsheets. The BA will manage these projects, facilitating and supporting the business users in defining requirements and writing/executing test scripts.
Responsibilities :
• Assist business users in defining user requirements and configuration specifications for regulated activity performed in third-party software applications;
• Assist business users in developing and executing 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 Medpace 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;
• Assist in gathering evidence during sponsor audits and regulatory inspections.
Qualifications :
• Bachelor’s degree or higher in a Clinical, Science, or Technical field;
• Proven ability to manage projects.
• Excellent communication skills, and ability to foster and maintain relationships with non-technical business users;
• Excellent writing skills;
• Competent in eliciting requirements from non-technical domain experts;
• Knowledge of system validation and software testing methodologies (experience in pharmaceutical GxP environments is a plus!);
• Knowledge of risk management strategies, and adapting testing strategy accordingly.
#LI-Hybrid
Medpace Overview :
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach.
We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?:
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Cincinnati Perks
• Cincinnati Campus Overview
• Hybrid work-from-home options (dependent upon position and level)
• Competitive PTO packages, starting at 20+ days
• Competitive compensation and benefits package
• Flexible work schedule
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives
• Community involvement with local nonprofit organizations
• Discounts on local sports games, fitness gyms and attractions
• Modern, ecofriendly campus with an on-site fitness center
• Structured career paths with opportunities for professional growth
• Discounted tuition for UC online programs
Awards
• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
EO/AA Employer M/F/Disability/Vets
Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Compliance Business Analyst to join our System Validation team. The BA will work with internal business users in other Medpace departments to validate third-party software applications.
These applications include, but are not limited to, analytical instrument software and custom calculation Excel spreadsheets. The BA will manage these projects, facilitating and supporting the business users in defining requirements and writing/executing test scripts.
Responsibilities :
• Assist business users in defining user requirements and configuration specifications for regulated activity performed in third-party software applications;
• Assist business users in developing and executing 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 Medpace 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;
• Assist in gathering evidence during sponsor audits and regulatory inspections.
Qualifications :
• Bachelor’s degree or higher in a Clinical, Science, or Technical field;
• Proven ability to manage projects.
• Excellent communication skills, and ability to foster and maintain relationships with non-technical business users;
• Excellent writing skills;
• Competent in eliciting requirements from non-technical domain experts;
• Knowledge of system validation and software testing methodologies (experience in pharmaceutical GxP environments is a plus!);
• Knowledge of risk management strategies, and adapting testing strategy accordingly.
#LI-Hybrid
Medpace Overview :
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach.
We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Why Medpace?:
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Cincinnati Perks
• Cincinnati Campus Overview
• Hybrid work-from-home options (dependent upon position and level)
• Competitive PTO packages, starting at 20+ days
• Competitive compensation and benefits package
• Flexible work schedule
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives
• Community involvement with local nonprofit organizations
• Discounts on local sports games, fitness gyms and attractions
• Modern, ecofriendly campus with an on-site fitness center
• Structured career paths with opportunities for professional growth
• Discounted tuition for UC online programs
Awards
• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
EO/AA Employer M/F/Disability/Vets
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