Medpace
From Medpace's careers page
Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.
Our corporate activities are growing rapidly, and we are currently seeking a full-time Software Testing Manager to join our Information Technology team. This position will manage a team of software testing engineers and software validation projects to implement effective and high quality software solutions. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you!
Lead validation staff in developing, coordinating, and maintaining full SDLC validation deliverables for Medpace regulated software applications, including Validation & Test Plans, User Requirements & Functional Specifications, Functional & User Acceptance Testing, Traceability Matrices, and Validation Summary Reports;
Coordinate and assign systems and projects to validation staff according to priorities, timelines and availability;
Maintain oversight of validation staff in managing change control of Medpace software applications;
Ensure compliance of Medpace computer systems with GxP and SOx regulatory requirements;
Ensure compliance of system validation Standard Operating Procedures (SOPs) with regulatory requirements;
Ensure consistency of systems validation SOPs with best practices of industry;
Lead validation team in implementing tools and procedures to facilitate validation and documentation activities; and
Participate in Sponsor audits;
Bachelor's Degree;
7+ years of experience in SDLC, testing, and validation, preferably in an Agile environment and/or regulated industry;
Advanced knowledge of software development life cycle;
Knowledge and understanding of the application of Risk Management concepts;
Excellent analytical, written, and oral communication skills;
Previous supervisory experience is preferred; and
Experience in the regulated healthcare industry, with working knowledge of Good Clinical Practice and 21 CFR Part 11, is a plus!
Medpace Overview
Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.
When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.
Purpose-Driven Work
Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence
Collaborative Culture
Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
Leadership throughout Medpace is both accessible and approachable
Continuous Growth & Development
Office based environment with on-site mentors
Defined career paths with clear advancement opportunities
Industry renowned onboarding and training programs designed to accelerate professional development
Ongoing training and continuous learning opportunities throughout your career
An environment that encourages employees to influence change, contribute ideas, and grow quickly
Other Employee Benefits
Competitive compensation programs that recognize and reward performance
Comprehensive health, wellness, retirement, and PTO benefits
Office based culture with occasional WFH that provides flexibility for eligible positions after training
Company-sponsored social events and intramural sports
Cincinnati Headquarters Experience
A modern corporate campus designed to support collaboration and productivity
Multiple on-site dining options in the heart of Madison Square
Free on-site parking
Convenient access to on-site 24-7 fitness and wellness facilities
What to Expect Next
A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.
Lead validation staff in developing, coordinating, and maintaining full SDLC validation deliverables for Medpace regulated software applications, including Validation & Test Plans, User Requirements & Functional Specifications, Functional & User Acceptance Testing, Traceability Matrices, and Validation Summary Reports;
Coordinate and assign systems and projects to validation staff according to priorities, timelines and availability;
Maintain oversight of validation staff in managing change control of Medpace software applications;
Ensure compliance of Medpace computer systems with GxP and SOx regulatory requirements;
Ensure compliance of system validation Standard Operating Procedures (SOPs) with regulatory requirements;
Ensure consistency of systems validation SOPs with best practices of industry;
Lead validation team in implementing tools and procedures to facilitate validation and documentation activities; and
Participate in Sponsor audits;
Bachelor's Degree;
7+ years of experience in SDLC, testing, and validation, preferably in an Agile environment and/or regulated industry;
Advanced knowledge of software development life cycle;
Knowledge and understanding of the application of Risk Management concepts;
Excellent analytical, written, and oral communication skills;
Previous supervisory experience is preferred; and
Experience in the regulated healthcare industry, with working knowledge of Good Clinical Practice and 21 CFR Part 11, is a plus!
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