Clinical Lead

5 days ago


Remote, Oregon, United States Premier Research Full time
Job Title: Principal Clinical Lead

Premier Research is seeking a highly experienced Principal Clinical Lead to join our Clinical Management team. As a key member of our team, you will be responsible for driving global study and/or program clinical teams, maximizing the efficiencies of the clinical team across studies/programs, and overseeing clinical team tracking and analysis of open action items, protocol deviations, and communication reports.

Key Responsibilities:
  • Acts as a leader driving global study and/or program clinical team and departmental engagement, maximizes the efficiencies of the clinical team across studies/programs
  • Oversight of clinical team tracking and analysis of open action items, protocol deviations, and communication reports
  • Completes/contributes to the review of the protocol/study design, informed consent forms, case report forms, and other study documents/plans, or delegates to the assigned CL
  • Applies a risk-based quality management mindset, contributes to the risk management plan, and supports set up of adaptive risk monitoring system with the study team as applicable
  • Works with all functional leads and sponsor to identify data-related issues and risks to clinical activities; assists CLs in the development of mitigation plans to minimize risk
  • Supports the PM, regional CLs, and/or appropriate line managers to ensure team members are adequately resourced to the project for the entire duration of the study
  • Oversight of financial health of clinical activities including support with identifying out-of-scope tasks from the Premier clinical team and ensures pre-approval of these tasks by the PM and Sponsor, as required
Requirements:
  • Bachelor's degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field; or equivalent work experience
  • 10 years of clinical research experience as a CRA, CL, or PM of which at least 4 years of clinical monitoring (or related) experience is required
  • 5 or more years of previous Clinical Oversight experience or equivalent (PM-CL), with priority for rare disease and cell & gene therapy trial management experience
  • Provided guidance, mentoring, and training for Clinical Leads on a global study and/or program clinical program
  • Supported clinical staff as a Subject Matter Expert for processes, systems, or tools
  • Expert presentation skills, including bid defense experience
Why Choose Premier Research?
  • Premier Research is more than a company – it's a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
  • Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
  • Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

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