[Remote] Contract – Trial Master File (TMF) Manager at Cytokinetics

Remote

Apply Now

Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Biopharmaceutical, PharmaceuticalIndustries

Requirements

Bachelor’s Degree preferred
5+ years’ experience managing or supporting TMF activities

Responsibilities

Review and approve all applicable TMF Plans (e.g., TMF Index, internal/external TMF Plan, Migration Plans)
Drive adherence to Cytokinetics’ TMF SOPs, policies, and regulatory requirements
Oversee setup, maintenance, transfer, and archival of TMFs in compliance with study timelines
Perform oversight and quality review of eTMF documents uploaded into the Cytokinetics (CK) eTMF
Identify and mitigate TMF-related risks, quality issues, and compliance gaps; initiate or support corrective and preventive actions (CAPA) as needed
Support inspection preparation activities, including document retrieval, audit trail verification, and readiness assessments
Lead or coordinate periodic TMF reviews to ensure TMF completeness, timeliness, and quality across assigned studies
Facilitate TMF Index update meetings, TMF Reviews, and related Module Training sessions for study teams and partners
Conduct ongoing quality control (QC) of eTMF documents for accuracy, metadata compliance, and completeness
Maintain comprehensive tracking of TMF quality issues and ensure all queries are addressed in a timely manner
Provide regular TMF status and compliance reports to the Study Lead and key stakeholders
Review and approve all applicable TMF-related plans, including migration and archival strategies
Monitor TMF metrics, KPIs, and dashboards; proactively identify risks and escalate as needed to ensure ongoing inspection readiness
Participate in continuous improvement activities to enhance eTMF processes, templates, and system functionality (e.g., Veeva Vault TMF)
Serve as the primary TMF point of contact for assigned studies, collaborating closely with Clinical Operations, Regulatory, Data Management, and CRO/vendor partners
Act as TMF business process SME, providing operational experience on TMF related process to internal and external TMF stakeholders
Facilitate and document eTMF status calls to discuss TMF progress, issues, metrics, and other key updates
Lead or support TMF governance forums (e.g., TMF Strategy Meetings, TMF Educational Workshops, Vendor Oversight Meetings)
Clarify functional document ownership, submission expectations, and TMF Index alignment with study teams
Provide TMF process training and mentorship to internal and external stakeholders to promote compliance and consistency
Prepare and maintain agendas, minutes, and action logs for all TMF-related meetings
Stay current on global regulations (FDA, EMA, MHRA, PMDA) and evolving industry standards, including CDISC TMF Reference Model, ALCOA+, ICH E6(R2), GCP, and GDP

Skills

TMF Management

eTMF

TMF Plans

SOPs

CAPA

Inspection Readiness

Quality Review

Risk Mitigation

Clinical Operations

Regulatory Compliance

Cytokinetics

Develops drugs for muscle function disorders

About Cytokinetics

Cytokinetics focuses on developing medicines that improve muscle function for patients with cardiovascular and neuromuscular diseases. Their products are small molecule drugs designed to either enhance or inhibit muscle function, tailored to specific therapeutic needs. The company has a pipeline of drugs, including omecamtiv mecarbil and reldesemtiv, which are in various stages of clinical trials. Unlike many competitors, Cytokinetics emphasizes rigorous scientific research and has conducted over 50 clinical trials to ensure the effectiveness of its treatments. The goal is to bring new therapies to market that address the unmet needs of patients suffering from conditions like heart failure, ALS, and HCM.

South San Francisco, CaliforniaHeadquarters

1998Year Founded

$58.4MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Risks

Increased competition could impact market share and profitability.

Potential delays in clinical trials could hinder drug commercialization.

Dependence on strategic partnerships may expose Cytokinetics to risks if challenges arise.

Differentiation

Cytokinetics focuses on muscle activators and inhibitors for cardiovascular and neuromuscular diseases.

The company has a robust pipeline including omecamtiv mecarbil and aficamten.

Cytokinetics engages in strategic partnerships, like with Sanofi, to expand market reach.

Upsides

Recent investments indicate strong interest in muscle activators and inhibitors.

Strategic partnerships, like with Sanofi, expand market reach and potential revenue.

Significant funding from Royalty Pharma supports commercial launch and R&D advancements.

Land your dream remote job 3x faster with AI

Try Jobo Free