Manager/Senior Manager, Records Management

Job not on LinkedIn

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $110k - $160k / year

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Codera

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Codera is a B2B company that partners with biotechnology and pharmaceutical companies to provide end-to-end drug development expertise and infrastructure. It supports clients across the drug development lifecycle with technical, operational, and infrastructure services to help advance therapeutic programs.

📋 Description

• Review study documents received from study teams for completeness and accuracy and upload them to the Trial Master File (TMF) • Perform quality control and quality reviews of TMF documents according to SOPs, work instructions, and guidance documents • Ensure documents failing TMF quality control or review are remediated and provide best-practice recommendations • Support TMF and CTMS inspection readiness for clinical studies • Provide feedback, support, and training to study teams on quality documentation management practices • Conduct TMF educational workshops and training as needed • Address questions about document filing and TMF system use • Maintain Essential Document Lists (EDLs) • Perform secondary review of site Essential Document Packages for site activation and Investigational Product release • Maintain the Clinical Trial Management System (CTMS), including study-, country-, and site-level updates, and review entries for accuracy • Contribute to TMF QC tools and materials, including the QC Tool, QC Manual, Doc Owner Manual, and TMF newsletters • Maintain current knowledge of the TMF Reference Model, industry best practices, and applicable regulatory considerations • Assist with inspection and audit activities, including preparation and corrective action plans • Execute other duties as assigned

🎯 Requirements

• Minimum 2 years of relevant clinical research and TMF experience required • Understanding of the clinical trial process and experience handling clinical trial-related documents required • Previous experience in electronic TMFs; Veeva preferred • Strong knowledge of ICH-GCP guidelines and regulatory requirements related 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 • Strong organizational skills with outstanding attention to detail and follow-through • Highly resourceful and adaptable to effectively support multiple competing demands and changing priorities • Proactive approach to problem-solving with strong decision-making capabilities • Fully proficient in MS Office Suite and internet research