Manager, Trial Master File (TMF) Operations at Eikon Therapeutics

Millbrae, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, BiotechnologyIndustries

Requirements

Task-driven and process-oriented individual dedicated to delivering project success by ensuring quality, compliance, and timeliness of TMF documents
Strong communication skills to work well as part of a team and independently
Detail-oriented with ability to escalate non-compliance or quality issues to stakeholders in a timely manner
Minimum of 3 days a week onsite presence in Jersey City (NJ) or Millbrae (CA) offices (or more as business needs require)
Knowledge of applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines, and study-specific processes/requirements

Responsibilities

Ensures all TMF related tasks meet expectations and are delivered in accordance with applicable SOPs, 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 inspection readiness 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, technical (Quality) QC of uploaded documents, initiating Quality Issue workflow, identifying and collecting incomplete/missing/expired documents, and collaborating with functional area teams and vendors to resolve discrepancies
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 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

Skills

Key technologies and capabilities for this role

Trial Master FileTMF OperationsClinical TrialsRegulatory ComplianceDocument ManagementQuality MonitoringInspection ReadinessStakeholder ManagementGCP ComplianceProcess Optimization

Questions & Answers

Common questions about this position

Is this role remote or does it require office presence?

The role requires a minimum of 3 days a week of onsite presence (or more as business needs require) in either the Jersey City (NJ) or Millbrae (CA) offices.

What skills and qualities are needed for the Manager, TMF Operations role?

Candidates need to be task-driven, process-oriented, dedicated to quality, compliance, and timeliness, with strong communication skills, ability to work in a team and independently, and detail-oriented with timely escalation of issues.

What is the salary or compensation for this position?

This information is not specified in the job description.

What does the company value in terms of work environment and team collaboration?

The company emphasizes effective management, operational excellence, high-performance delivery of clinical studies, and significant team growth and collaboration, requiring onsite presence to support these goals.

What makes a strong candidate for this TMF Operations Manager role?

A strong candidate is task-driven, process-oriented, with strong communication skills, detail-oriented, and experienced in ensuring TMF quality, compliance, and timeliness while collaborating with study teams.

Eikon Therapeutics

Biotech startup developing innovative medicines

About Eikon Therapeutics

Eikon Therapeutics focuses on discovering and developing new medicines in the pharmaceutical industry. The company employs advanced technologies to study biological systems, aiming to identify new drug targets by examining the dynamic aspects of biology rather than just static chemical processes. Their team consists of diverse professionals, including data scientists, chemists, and engineers, which allows them to combine science and engineering to create new therapies that aim to improve and extend life. A key feature of Eikon's approach is their proprietary single-molecule tracking (SMT) platform, which enables rapid visualization of protein movements in living cells. This technology, along with artificial intelligence and automation, allows for precise inventorying of molecular interactions. Eikon Therapeutics targets patients with serious diseases who need effective treatments, generating revenue through the development and commercialization of their therapies.

Hayward, CaliforniaHeadquarters

2019Year Founded

$750.8MTotal Funding

SERIES_CCompany Stage

AI & Machine Learning, BiotechnologyIndustries

201-500Employees

Benefits

401(k) Company Match

Medical (premiums covered by Eikon at 95%)

Dental Insurance

Vision Insurance

Mental Health Support

Unlimited Paid Time Off

Paid Holidays

Life Insurance

Enhanced Parental Leave

Daily subsidized lunch program

Risks

Competition from biotech unicorns like Abogen Biosciences is increasing.

Integrating new clinical-stage assets may delay drug development timelines.

Reliance on SMT technology risks obsolescence from emerging molecular biology technologies.

Differentiation

Eikon uses proprietary single-molecule tracking for real-time protein movement analysis.

The company integrates AI and automation for large-scale molecular interaction studies.

Eikon's diverse team combines expertise in science, engineering, and technology.

Upsides

Growing interest in SMT technology boosts Eikon's drug discovery potential.

Partnerships with AI firms enhance Eikon's drug candidate identification.

Rising demand for precision medicine aligns with Eikon's focus on dynamic biology.

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