Clinical Data Management Systems Administrator

About the Role: We are looking for a Clinical Data Management Systems Administrator to join our team. In this role, you will provide system administration and system oversight across all clinical systems, ensuring consistent processes and appropriate training documentation.

This is a remote position, and you can work from home in most locations within the United States.

Responsibilities:

• Perform all required day-to-day system administration activities for all clinical systems, including managing configurations and requirements, troubleshooting issues, providing support to system users, and interfacing with system vendors
• Lead and/or facilitate the Clinical Affairs validation of clinical systems. This can include cross-functional testing and validation efforts, managing system level testing and validation documentation, obtaining stakeholder input for system configurations, and managing system integrations. Serve as resource for assistance with study team UAT activities and system archival activities
• Serve as expert resource, providing recommendations and best practices related to system configurations for study-specific uses, and, where applicable, promote the utilization of new and existing technologies (e.g., reporting tools, batch uploading tools). Communicate system-related concerns, updates, and issues to functional leadership, internal stakeholders, and system users as needed
• Manage system level configuration documentation (e.g., Rave core configuration, eTMF Non-administrative Changes), and manage a list of enhancement requests and defects known to impact active Clinical Systems and liaise with vendor technical contacts to address technical issues
• Collaborate with internal stakeholders to identify training requirements for system access. Manage system level training and documentation for all users across systems managed by Clinical Affairs (e.g., EDC, CTMS, eTMF, MITA)
• Perform user role administration activities including granting, modifying, and revoking user access. Coordinate with study teams to conduct regular system and study level user reviews (e.g., quarterly EDC reviews) and troubleshoot user access issues as needed
• Partner with Clinical Quality Assurance (CQA) to promote quality and regulatory compliance with regard to clinical systems. Support submission and audit activities related to system and user documentation
• Keep up with industry best practices and emerging regulatory expectations in regard to computer systems validation
• Participate in process improvement initiatives
• Maintain knowledge of industry and regulatory trends as required to meet business needs and perform the responsibilities of the position

Required Qualifications:

• Bachelor’s degree or equivalent in background and experience
• Experience with one or more of the following systems, Medidata EDC and Imaging Transfer, Medrio EDC, Viedoc EDC, Veeva Vault eTMF, and/or CTMS
• Experience with Clinical Research Systems
• Experience working on cross-functional teams
• Knowledge of regulations and standards for use of clinical systems, namely 21 CFR part 11 (including predicate rules), ICH E6, and ISO-13841 and -14155
• Proficiency in desktop and/or web applications
• Organizational skills, flexibility, and ability to multi-task
• Strong verbal and written communication skills
• Ability to quickly learn new tools and troubleshoot technical problems
• Ability to travel up to 5%

Desired Qualifications:

• Experience with Clinical Data Management in medical device / pharmaceutical industry or equivalent
• Experience with computer system development lifecycle, including software validation testing and database testing
• Experience with systems validation processes used within a clinical research environment

Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s remote working policies, from the country in which they are employed. For fully remote roles, the following locations are not eligible for new fully remote work arrangements: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).

What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.

We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit-sharing”. Learn more at gore.com/careers/benefits

We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.

Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.

Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.

Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.

Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact

Additional Information