Clinical Trial Manager

Location: Emeryville, CA
Department: Clinical Development - Fintepla

Position Summary

The Clinical Trial Manager (CTM) is responsible for the day to day management of clinical trials, vendors, and clinical trial sites. This position will work closely with cross-functional teams to ensure that clinical trials are conducted in a manner compliant with SOPs, ICH/GCP Country specific regulatory guidelines, company goals, timelines and budgets. This position is responsible for ensuring achievement of his/her own project goals and objectives. This person is a capable manager with the ability to perform and manage the duties and functions necessary to deliver a quality study on time and within budget.

Responsibilities

  • Participates in CRO/vendor selection process for outsourced
  • Oversees vendor activities to include reviewing monitor visit reports, participating in vendor meetings, supporting development/management of vendor oversight plans/trackers, identifying and mitigating/escalating issues/risks as appropriate.
  • May be a point of responsibility for oversight of CRO and additional vendors.
  • Manages/oversees site start up, subject recruitment, enrollment, study management, monitoring, site management, clinical trial master files, and data clean
  • Participates in CRF design, project plans and clinical report
  • Proactively identifies potential study issues/risks and recommends/implements
  • Supports the management of study related activities including timelines, study visits, site selection, site initiation, site management, study drug management, closeout activities, development/management of trackers, data sharing forums.
  • Assists in the development/review and approves regulatory and other required study documents for GCP compliance for US, EU and other parts of the
  • Manages ongoing communication of operation issues and provide accurate progress reports on assigned activities to study
  • May be responsible for managing/overseeing site and/or vendor budget
  • Participates in/manages quality data cleaning activities such as data listing reviews, TMF reviews.
  • Participates in/facilitates project team discussions/meetings.
  • Leads and/or participates in quality improvement and process improvement initiatives.
  • Other duties as assigned.

Core Competencies

  • Manages ambiguity
  • Collaboration
  • Action oriented
  • Plans and aligns

Qualifications

  • Bachelors degree or equivalent required (scientific or healthcare discipline preferred)
  • 5+ years study management (or equivalent) experience in clinical and drug development
  • Experienced in managing CROs, specialty labs and outside vendors
  • Experience in start-up, data cleaning, and close out
  • Working knowledge of ICH GCP guidelines
  • Excellent planning and organizational skills
  • High level of initiative and ability to work independently

Other Skills

  • Excellent written and verbal communication skills
  • Possess excellent interpersonal skills
  • Proficiency with MS Word, Excel, Outlook, Project and PowerPoint
  • Demonstrated creativity and innovation to support projects and initiatives
  • Attention to detail
  • Knowledge of EU Country regulations and experience developing EU country specific informed consents

Special Working Conditions

  • Ability to travel as required

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