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Senior Clinical Trial Manager

Faraday Pharmaceuticals, Inc., SEATTLE WA

This job is no longer available.

Faraday Pharmaceuticals is a biopharmaceutical company focused on the research and development of elemental reducing agents. These therapeutic agents have potential applications for treatment of critical care illnesses. 


The Sr. Clinical Trial Manager (Sr. CTM) will be responsible for the operational management and oversight of Faraday’s upcoming phase 3 study in the treatment of acute ST segment elevation myocardial infarction (STEMI) and reperfusion injury.


The Sr. CTM will work closely with the Medical Monitor and other cross-functional representatives within both Faraday Pharmaceuticals and designated CROs, including Data Management, Biostatistics, Regulatory, Quality Assurance to ensure successful completion of all clinical activities and project deliverables within the required time frame and budget. The Sr. CTM will also provide oversight of the CRO and other third-party vendors. 


Primary Responsibilities

  • Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study specific manuals and procedures
  • Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
  • Lead or assist the identification and hiring of appropriate CROs and third-party study vendors
  • Oversee performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate as appropriate
  • Identify, select, and monitor performance of investigational sites for clinical studies; ensure accurate and timely visit reports from all site visits
  • Track and report on progress of study including site activation, patient enrollment, data collection, and monitoring visits
  • Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team
  • Negotiate and manage the budgets and payments for investigative sites, if applicable
  • Assist with CRA and third-party vendor training on protocols and practices
  • Develop and maintain good working relationships with investigators and study staff
  • Manage investigational product (IP) accountability process
  • Responsible for review or approval of IP release packages
  • Perform initial review of CRO and other third-party study vendor invoices to ensure that work is performed in accordance with scope of work
  • Ensure clinical data review of data listings and summary tables, including query generation


Qualifications

  • BS/BA in Life Science or related discipline
  • 6-8 years clinical operations experience in the pharmaceutical industry; with a significant amount on the sponsor side
  • Significant experience managing industry sponsored clinical (pharmaceutical) trials; management of large international clinical trials preferred
  • Global Phase III experience and cardiology drug development highly preferred
  • Cross-functional team leadership experience
  • Experience managing vendors, including performance assessments and finances (invoice review, change order management, budget reforecasting, etc.)
  • Strong interpersonal, communication (written and verbal), and organizational skills
  • Demonstrated ability to work independently as well as part of a multi-functional study team
  • Able to motivate a team to work effectively
  • Able to solve problems under pressure
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