Manager/Senior Manager, Records Management

This is a fully remote position, open to applicants in California.

📋 Description

• Evaluate study documentation provided by study teams for completeness and accuracy, and upload them to the Trial Master File (TMF).

• Conduct quality control and quality reviews of TMF documents in accordance with SOPs, work instructions, and guidance materials.

• Ensure that documents failing TMF quality control or review are corrected and offer best-practice recommendations.

• Assist with TMF and CTMS inspection readiness for clinical trials.

• Provide feedback, support, and training to study teams on effective quality documentation management practices.

• Facilitate TMF educational workshops and training as necessary.

• Address inquiries regarding document filing and the use of the TMF system.

• Maintain Essential Document Lists (EDLs).

• Conduct secondary reviews of site Essential Document Packages for site activation and Investigational Product release.

• Oversee the Clinical Trial Management System (CTMS), including updates at the study, country, and site levels, while ensuring the accuracy of entries.

• Contribute to TMF QC tools and materials, including the QC Tool, QC Manual, Doc Owner Manual, and TMF newsletters.

• Stay updated on the TMF Reference Model, industry best practices, and relevant regulatory considerations.

• Assist with inspection and audit activities, including preparation and corrective action planning.

• Perform additional duties as assigned.

⛳️ Requirements

• A minimum of 2 years of relevant clinical research and TMF experience is required.

• A solid understanding of the clinical trial process and experience managing clinical trial-related documents is essential.

• Previous experience with electronic TMFs is required; experience with Veeva is preferred.

• Strong knowledge of ICH-GCP guidelines and regulatory requirements pertaining to clinical document management.

• Self-motivated, well-organized, detail-oriented, with excellent written and verbal communication skills.

• Ability to achieve high-performance goals and meet deadlines in a fast-paced environment.

• Excellent organizational skills with a keen attention to detail and follow-through.

• Highly resourceful and adaptable to effectively manage multiple competing demands and changing priorities.

• A proactive approach to problem-solving with strong decision-making skills.

• Fully proficient in MS Office Suite and internet research.

🏝️ Benefits

• Comprehensive health insurance plans.

• Opportunities for professional development and growth.

• Flexible working hours and remote work options.

• Collaborative and inclusive work environment.