Manager, Records Management – TMF Quality Control Specialist

Job not on LinkedIn

🕒 May 5

🏄 California – Remote

🏄 California – Remote

💵 $115k - $145k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👔 Manager

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Codera

WebsiteLinkedInAll Job Openings

11 - 50 employees

🧬 Biotechnology

💊 Pharmaceuticals

🤝 B2B

Biotechnology • Pharmaceuticals • B2B

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

• Provide support for TMF activities by ensuring documents uploaded to the TMF adhere to Standard Operating Procedures, ICH GCP guidelines and other regulatory requirements • Act as a TMF Subject Matter Expert (SME) and work with the study teams to ensure the TMFs and CTMS for clinical studies are inspection ready at all times • Review study documents received from the study teams for completeness and accuracy and upload to the Trial Master File (TMF) • Perform quality control of documents submitted to the TMF per SOPs, Work Instructions and Guidance Documents • Ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations, as needed • Conduct TMF educational workshops/training, as needed • Address TMF questions pertaining to how documents are filed, and user questions related to the TMF system • Ensure Essential Document Lists (EDLs) are maintained on an ongoing basis • Perform the secondary review of site Essential Document Packages per applicable SOPs to ensure sites meet the requirements for site activation and Investigational Product (IP) release • Responsible for Clinical Trial Management System (CTMS) maintenance, including study, country and site level updates and reviewing CTMS entries for accuracy • Contribute to TMF QC Tools as needed to match with evolving business processes (incl. QC Tool, QC Manual, Doc Owner Manual, TMF Newsletters) • Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory considerations as applicable to the job duties • Assist with inspection/audit related activities (e.g., preparation, corrective action plans)

🎯 Requirements

• Minimum 2 years of relevant clinical research and TMF experience required • Understanding of the clinical trial process, experience in 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 • Must be self-motivated, well-organized, detail-oriented, and have excellent written and verbal communication skills • Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment • Strong organization skills with outstanding attention to detail and follow-through • Must be highly resourceful and adaptable to effectively support multiple competing demands and changing priorities • Demonstrated proactive approaches to problem-solving with strong decision-making capabilities • Must be fully proficient in MS Office Suite and internet research.

🏖️ Benefits

• employer sponsored insurance plans including medical, dental and vision coverage • generous paid time off • retirement plan options • additional wellness and professional development programs