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

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

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Requirements

Bachelor’s Degree preferred
5+ years’ experience managing or supporting TMF activities
Experience with TMF SOPs, policies, and regulatory requirements
Experience with eTMF systems (e.g., Veeva Vault TMF)
Knowledge of global regulations (FDA, EMA, MHRA, PMDA)
Knowledge of CDISC TMF Reference Model, ALCOA+, ICH E6(R2), GCP, and GDP
Strong cross-functional communication skills
Detail-oriented and proactive

Responsibilities

Review and approve all applicable TMF Plans
Drive adherence to Cytokinetics’ TMF SOPs, policies, and regulatory requirements
Oversee setup, maintenance, transfer, and archival of TMFs
Perform oversight and quality review of eTMF documents
Identify and mitigate TMF-related risks, quality issues, and compliance gaps
Support inspection preparation activities
Lead or coordinate periodic TMF reviews
Facilitate TMF Index update meetings, TMF Reviews, and related Module Training sessions
Conduct ongoing quality control of eTMF documents
Maintain comprehensive tracking of TMF quality issues
Provide regular TMF status and compliance reports
Review and approve all applicable TMF-related plans
Monitor TMF metrics, KPIs, and dashboards
Participate in continuous improvement activities to enhance eTMF processes
Serve as the primary TMF point of contact for assigned studies
Act as TMF business process SME
Facilitate and document eTMF status calls
Lead or support TMF governance forums
Clarify functional document ownership, submission expectations, and TMF Index alignment
Provide TMF process training and mentorship
Prepare and maintain agendas, minutes, and action logs for all TMF-related meetings
Stay current on global regulations and evolving industry standards

Skills

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.

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