EPM Scientific - Phaidon International
Director, TMF Operations
EPM Scientific - Phaidon International, Jersey City, New Jersey, United States, 07390
Title: Director of Clinical Operations, Greater Boston Area, HybridSalary : $200,000-$230,000Company Summary:
We just partnered with one of the hottest biotech's around at the moment that is growing its clinical team ahead of a large phase 3 Oncology trial.This company is founded and led by some of the industries brightest with their C suite coming from well-established big pharma. Here, they were able to get multiple blockbuster drugs approved. This company is one that has potential well beyond just one blockbuster drug due to their proprietary drug discovery platform. This exciting company has applications in oncology, neurology and immunology.With nearly $800 million in funding they have a cash runway for years to come, and their current pipeline is robust. In addition to the phase 3 you will be working on they have 11 other indication in development.The director of TMF Operations will be responsible for:Lead TMF Operations to support Clinical Research and Development.Oversee TMF vendor relationships, resolving issues and ensuring compliance.Ensure proper chain-of-custody at on-site and off-site TMF facilities.Develop and implement TMF processes, procedures, and training materials that comply with regulations and industry standards.Collaborate with cross-functional teams to maintain TMF completeness and accuracy throughout the trial lifecycle.Ensure quality control of TMF documents from start-up to archival.Monitor and report TMF metrics to senior management, highlighting improvement areas.Report TMF readiness to Clinical Trial Teams, including study-specific reviews.Identify root causes of performance issues and implement corrective actions.Stay updated on regulatory changes and best practices for continuous improvement.Manage eTMF platform configurations and monitor their impact.Oversee the sponsor archive's contents and access.The director of clinical operations should have the following qualifications:10-12 years of experience with TMF operationsStrong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operationsExperience with electronic Trial Master File systems (e.g., Veeva) and related technology platformsProficient knowledge of DIA TMF Reference ModelExperience in managing a team and providing leadership to drive performanceAbility to work onsite at least 3 days a weekBenefits401k with company matching.Health insurance with excellent family plan.Pre-IPO with equity offerings.
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We just partnered with one of the hottest biotech's around at the moment that is growing its clinical team ahead of a large phase 3 Oncology trial.This company is founded and led by some of the industries brightest with their C suite coming from well-established big pharma. Here, they were able to get multiple blockbuster drugs approved. This company is one that has potential well beyond just one blockbuster drug due to their proprietary drug discovery platform. This exciting company has applications in oncology, neurology and immunology.With nearly $800 million in funding they have a cash runway for years to come, and their current pipeline is robust. In addition to the phase 3 you will be working on they have 11 other indication in development.The director of TMF Operations will be responsible for:Lead TMF Operations to support Clinical Research and Development.Oversee TMF vendor relationships, resolving issues and ensuring compliance.Ensure proper chain-of-custody at on-site and off-site TMF facilities.Develop and implement TMF processes, procedures, and training materials that comply with regulations and industry standards.Collaborate with cross-functional teams to maintain TMF completeness and accuracy throughout the trial lifecycle.Ensure quality control of TMF documents from start-up to archival.Monitor and report TMF metrics to senior management, highlighting improvement areas.Report TMF readiness to Clinical Trial Teams, including study-specific reviews.Identify root causes of performance issues and implement corrective actions.Stay updated on regulatory changes and best practices for continuous improvement.Manage eTMF platform configurations and monitor their impact.Oversee the sponsor archive's contents and access.The director of clinical operations should have the following qualifications:10-12 years of experience with TMF operationsStrong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operationsExperience with electronic Trial Master File systems (e.g., Veeva) and related technology platformsProficient knowledge of DIA TMF Reference ModelExperience in managing a team and providing leadership to drive performanceAbility to work onsite at least 3 days a weekBenefits401k with company matching.Health insurance with excellent family plan.Pre-IPO with equity offerings.
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