GENERAL SUMMARY: 

We are seeking a Clinical Records Associate for our TMF Operations Department Reporting to the Associate Director of TMF Operations. This position is responsible for collecting, reviewing, maintaining, and archiving essential documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and 4DMT’s Standard Operating Procedures (SOPs) as appropriate. 

RESPONSIBILITIES:  

• Responsible for TMF Oversight development and execution, ensuring all clinical documentation is being collected, handled, transferred, and stored via secured and authorized methods, ensuring compliance with global and local standards, requirements, and guidelines.
• Manage TMF performance objectives for end-to-end processes ensuring quality, timeliness, and completeness throughout the lifecycle of the study by overseeing and/or ensuring ongoing reviews to confirm documents are collected and maintained per ICH guidelines and global regulatory requirements.
• Perform the role of the Clinical Records Associate for all Clinical Trials at 4DMT throughout the TMF lifecycle, from study start-up and document collection to oversight and archiving.
• Participate in Quality Assurance audits and/or regulatory authority inspections.
• Support Study Teams to proactively maintain current Expected Documents List (EDL) counts and to file essential documents promptly according to TMF Plans and Indexes, including adjustments due to unanticipated events during trial conduct.
• Identify study-specific TMF compliance gaps (missing or low-quality documents) and track resolutions to closure quickly.
• Manage the performance of external vendors responsible for TMF-related deliverables.
• Escalate issues and/or process improvement suggestions and collaborate cross-functionally to define and implement solutions, Veeva Vault system changes, or corrective and preventative actions.
• Contribute to the development and improvement of department-level and cross-functional Standard Operating Procedures (SOPs), processes, systems, tools. 
• Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

QUALIFICATIONS: 

Education: 

• Applicants are expected to have either a bachelor’s degree (preferably in a scientific or healthcare-related field) or, in the absence of a formal degree, a minimum of four years of relevant training and work experience in document control.

Experience: 

• 2 years relevant experience including extensive experience with Veeva Vault TMF.
• 2+ years of TMF QC Review and knowledge of clinical documentation content required.

• Development and maintenance of TMF Plans.
• Demonstrated understanding of the DIA Reference Model filing structure and contents.
• Knowledge of and ability to apply applicable regulations and guidelines (e.g., ICH/GCP/Good Documentation Practice).
• Experience working with cross-functional teams to improve TMF compliance (quality, completeness, and timeliness). 

Required Skills:

• Expert knowledge of cross-functional TMF content requirements throughout the trial.
• Proficiency in Microsoft Office Suite for collaboration with team members. 
• Especially proficient in Excel for tracking, sorting, filtering, and managing large sets of metadata. 
• Excellent communication skills (written and verbal).
• Interpersonal skills, including conflict resolution in a fast-paced, deadline-driven environment.
• Strong attention to detail and organizational skills.
• Ability and drive to follow through on detailed tasks to closure.
• Analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.

Preferred Skills:

• Managing CROs performing TMF activities.
• Creating and using enterprise system reports to calculate metrics and troubleshoot issues.
• All aspects of clinical trial conduct (startup through close-out and TMF Archiving). 
• Experience with additional Veeva products such as CTMS or Vault RIM.
• Experience using collaborative tools like SharePoint and Microsoft Teams and Channels.

Base salary compensation range:

$85,000/yr - $107,000/yr

Bay Area Range: 

$95,000/yr - $124,000/yr

Please note that compensation varies on a variety of factors including location, experience, etc.