
Director, Records & Information Management - US - Remote
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Job Description
Who we are
We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What the Director, Records & Information Management does at Worldwide
The Director of Records & Information Management leads enterprise-wide records governance, driving strategic initiatives to enhance regulatory compliance, operational efficiency, and risk mitigation. This role is responsible for designing and executing a comprehensive records management program, including classification, retention, protection, and disposal of records in alignment with legal requirements, industry standards, and internal policies. The Director collaborates cross-functionally with Legal, Clinical Operations, Quality Assurance, and IT to advance the organization's information governance strategy and ensure consistent, compliant records practices.
What you will do
Records Governance & Compliance
Develop and maintain an enterprise-wide corporate records retention schedule and classification scheme.
Ensure compliance with applicable regulations (e.g., FDA, HIPAA, GDPR, 21 CFR Part 11) and internal policies.
Monitor and audit records management practices across departments.
Program Development & Implementation
Build and organize a Records and Information Management Department.
Lead the implementation of records management systems and tools.
Provide training and guidance to staff on records handling, retention, and disposal.
Establish procedures for secure storage, retrieval, and archiving of physical and electronic records.
Collaboration & Support
Partner with Legal, IT, and Clinical teams to support litigation holds, audits, and regulatory inspections.
Serve as a subject matter expert on records and information lifecycle management.
Support data privacy initiatives by ensuring proper handling of sensitive and personal data.
Risk Management & Disposal
Oversee secure and compliant destruction of records past retention periods.
Identify and mitigate risks related to information mismanagement or unauthorized access.
What you will bring to the role
Experience with electronic records management systems (e.g., Microsoft 365, MS Purview, SharePoint, OpenText, Veeva Vault).
Excellent organizational, communication, and project management skills.
Ability to work independently and collaboratively in a fast-paced, regulated environment.
Your experience
10+ years of experience in records and information management, preferably in a clinical research, pharmaceutical, or healthcare setting.
Bachelor's degree in Information Management, Library Science, Legal Studies, or related field.
Master's or certification (e.g., CRM, IGP) preferred.
Strong knowledge of regulatory requirements affecting records (FDA, ICH-GCP, HIPAA, GDPR).
Experience with electronic records management systems (e.g., Microsoft 365, MS Purview, SharePoint, OpenText, Veeva Vault).
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.
