Eikon Therapeutics · 7 hours ago
Manager, Trial Master File (TMF) Operations
Jersey City, NJ
Full-time
Onsite
Mid, Senior Level
$122K/yr - $133K/yr
4+ years expEikon Therapeutics is a new biopharmaceutical company employing revolutionary technology to discover novel treatments for life-threatening diseases. The Manager, TMF Operations role ensures a complete, accurate and high-quality Trial Master File (TMF) by collaborating with clinical study teams and maintaining regulatory inspection readiness for clinical trials.
BiotechnologyHealth CareLife ScienceMedical
Responsibilities
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
Qualification
Required
6+ years of experience with a Bachelor's degree; or 4+ years of experience with a post graduate degree
Experience in a pharmaceutical/biotechnology/CRO organization's TMF/records management function preferred
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
Preferred
Experience in a pharmaceutical/biotechnology/CRO organization's TMF/records management function preferred
Experience with eTMF; Veeva eTMF experience preferred but not mandatory
Experience in supporting audits and regulatory inspections desirable
Benefits
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
Company
Eikon Therapeutics
Eikon Therapeutics is a biopharmaceutical company that develops live-cell resolution microscopy and engineering for drug discovery.
201-500 employees
H1B Sponsorship
Eikon Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (19)
2023 (7)
2022 (3)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$1.12BKey Investors
The Column Group
2025-02-26Series D· $350.7M
2023-06-01Series C· $106M
2022-01-06Series B· $518M
Leadership Team
Roger Perlmutter
Chairman, President, and CEO
Michael Klobuchar
Chief Operating Officer
Recent News
General Catalyst
2025-12-26
2025-12-02
Company data provided by crunchbase