Full-Time

Senior Trial Master File

Tmf, Specialist

Updated on 12/5/2024

Cytokinetics

Cytokinetics

501-1,000 employees

Develops drugs for muscle function improvement

Biotechnology
Healthcare

Compensation Overview

$50 - $60Hourly

Senior

San Bruno, CA, USA

Hybrid/onsite position; candidate must be located in the Bay Area.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Word/Pages/Docs
Google Cloud Platform
Excel/Numbers/Sheets
Requirements
  • Bachelor’s Degree Required
  • 3+ years of Veeva Vault eTMF experience required.
  • 5+ years of experience working directly in TMF Operations within the clinical research or pharmaceutical industry. Experience with global clinical trials is highly desirable.
  • TMF Certification or TMF training optional but preferred (e.g., DIA’s TMF Certificate Program or LMK TMF University) or other relevant certifications.
  • This position will be a hybrid/onsite position with requirement for the candidate to be located in the Bay Area.
  • Working knowledge of clinical research documents across Research and Development (i.e., Regulatory, Clinical Supplies, Drug Safety, Biostatistics, etc.)
  • Experience in managing TMF documents during regulatory inspections.
  • Extensive experience in TMF management, with a deep understanding of GCP, GDP, ALCOA+ standards, and regulatory requirements.
  • Basic understanding of study and site management and overall trial planning and execution.
  • Basic understanding of ICH-GCP guidelines and FDA/MHRA/EMA/PMDA regulations.
  • Familiarity with MS Word, MS Excel (extra plus), and MS PowerPoint.
Responsibilities
  • Strategically manage the document lifecycle in Veeva Vault eTMF, including creation, version control, review, approval, and archival, ensuring alignment with study timelines and regulatory requirements.
  • Lead milestone TMF reviews, ensuring that all required documents are accurately filed and accessible.
  • Ensure that all TMF documentation meets regulatory standards and internal SOPs, proactively identifying and addressing potential compliance risks.
  • Lead efforts to identify, communicate, and resolve document inconsistencies, discrepancies, and gaps. Work closely with functional areas and the TMF Manager to implement corrective actions and prevent future issues.
  • Identify eTMF trends and commonly misfiled documents. Lead the creation and delivery of targeted training sessions for the TMF Community.
  • Oversee the proactive management of clinical documentation and trackers, ensuring that all documentation is up-to-date, compliant, and readily accessible.
  • Supports TMF System Administrator with activities related to TMF Migrations, such as QA Testing or Data Enrichment.
  • Act as a senior liaison between the TMF Manager, TMF Document Specialist, vendors, and study teams, providing expert guidance and support on TMF documentation requirements throughout the study lifecycle.
  • Collaborate with internal stakeholders to gather and provide critical information needed to execute the Expected Document List (EDL) requirements and expected numbers, ensuring alignment with the Study-Specific TMF Plan and TMF Index.
  • Serve as the Subject Matter Expert (SME) for TMF documents, providing consultation and guidance to study teams and TMF operations on complex document management issues.
  • Mentors TMF Document Specialist by providing guidance on essential document attributes, such as document classification and resolution of document queries. Furthermore, advises study team members on the best practices in document management.
  • Lead the monitoring of TMF processing metrics, ensuring that documents are processed, reviewed, and submitted in a timely manner. Use data-driven insights to identify areas for improvement.
  • Track and report on key performance indicators (KPIs) related to TMF quality, compliance, and processing efficiency. Provide strategic recommendations to improve TMF processes.
  • Provide regular TMF/eTMF status updates during Clinical Vendor Oversight Meetings and Study Operational Team meetings.
  • Ensure the TMF complies with all applicable regulatory requirements and guidelines.
  • Prepare for and support regulatory inspections and audits related to the TMF.

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.

Company Stage

IPO

Total Funding

$58.4M

Headquarters

South San Francisco, California

Founded

1998

Growth & Insights
Headcount

6 month growth

2%

1 year growth

1%

2 year growth

15%
Simplify Jobs

Simplify's Take

What believers are saying

  • Successful Phase III trial results for aficamten in treating obstructive hypertrophic cardiomyopathy (HCM) highlight the company's potential for market leadership in this area.
  • The $575M funding from Royalty Pharma ensures strong financial support for the commercial launch of aficamten and further R&D activities.
  • Recent investments and stock offerings indicate strong investor confidence and provide additional capital for growth and development.

What critics are saying

  • The late-stage biopharmaceutical market is highly competitive, with significant pressure to bring drugs to market quickly and efficiently.
  • Dependence on the success of clinical trials and regulatory approvals poses inherent risks, as any setbacks could delay commercialization and revenue generation.

What makes Cytokinetics unique

  • Cytokinetics focuses on muscle function improvement for cardiovascular and neuromuscular diseases, a niche area with high unmet medical needs.
  • The company has a robust pipeline of small molecule muscle activators and inhibitors, setting it apart from competitors with more generalized drug portfolios.
  • Strategic funding collaborations, such as the $575M deal with Royalty Pharma, provide significant financial backing for their R&D and commercialization efforts.

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