Manager, Trial Master File (TMF) Operations

Position

The Manager, TMF Operations role ensures a complete, accurate and high-quality Trial Master File (TMF) as the subject matter expert through proper, consistent documentation and proactive partner relationship with the clinical study teams.  This role will work directly with all functions (internal and external) who contribute to the TMF to ensure regulatory inspection readiness for clinical trials. In addition to ensuring TMF Quality, this role will assist in TMF set-up, document collection and filing, monitoring quality, timeliness, and completeness, and following-up with study teams to resolve TMF-related issues. 

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City (NJ), New York (NY), or Millbrae (CA) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

You are a task-driven and process-oriented individual that is dedicated to delivering project success by ensuring quality, compliance, and timeliness of TMF documents.  You have strong communication skills that enable you to work well as part of a team but are also successful working independently.  You are detail-oriented and escalate identified non-compliance or quality issues to appropriate stakeholders in a timely manner.

What You’ll Do

• Ensures all TMF related tasks meet expectations and are delivered in accordance with applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and executed study-specific processes/requirements.
• Sets up the TMF and Expected Document Lists (EDLs) by collaborating with relevant members of the study team and acts as the primary contact and point of escalation for TMF issues.
• Facilitates the creation, review, and approval of TMF plans and filing structures.
• Performs periodic TMF Quality, Timeliness and Completeness Reviews to maintain an inspection readiness state throughout the clinical trial.
• Facilitates the planning and execution of periodic TMF content reviews by accountable study TMF Content Reviewers.
• Identifies and informs study teams of TMF quality trends (e.g., rejection reasons, commonly misfiled documents, and/or non-compliance with plans or regulations).
• Supports documentation collection and filing activities, including:
  • Document scanning and indexing.
  • Perform technical (Quality) QC of uploaded documents.
  • Initiate Quality Issue workflow when document issues are identified.
  • Identify and work with functional areas to collect incomplete, missing and/or expired documents.
  • Collaborate with functional area teams and vendors to resolve discrepancies and ensure timely completion of internal tasks, as they relate to TMF deliverables.
• Executes TMF archival activities.
• Provides guidance to internal teams on performing functional QC of TMF documents.
• Participates in preparation/reconciliation of TMF documentation related to audits, inspections, and shipments.
• Supports risk mitigation strategies or corrective and preventative actions to document management issues.
• Supports TMF process development, improvement, and implementation including the development of procedural documents and/or job aids related to TMF activities.
• Provides feedback, support, and training to study teams to build knowledge and awareness of good, quality documentation management practices for clinical trials.

Qualifications

• Bachelor’s Degree or equivalent with 6+ years of experience in a pharmaceutical / biotechnology / CRO organization’s TMF / records management function.
• Experience in TMF management, knowledge of the TMF Reference Model, ALCOA+ standard, Good Documentation Practices, or relevant working experience in pharmaceutical/scientific environments.
• Experience with eTMF; Veeva eTMF experience preferred but not mandatory.
• Experience in supporting audits and regulatory inspections desirable.
• General knowledge of clinical trials and basic principles of overall trial planning and execution.
• Basic understanding of ICH-GCP guidelines and FDA/EMA/PMDA regulations.
• Familiarity with MS Word, MS SharePoint, MS Visio, Adobe Acrobat Professional, MS Excel, and MS PowerPoint.
• Ability to handle a high volume of tasks within a given timeline.
• Ability to interact with key stakeholders across Clinical Development functional areas.
• Ability to travel as required.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $122,000 to $133,000 depending on skills, competency, and the market demand for your expertise.