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Clinical Lead
2 months ago
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 play a critical role in driving global study and/or program clinical team and departmental engagement, maximizing the efficiencies of the clinical team across studies/programs.
Key Responsibilities:- Lead global study and/or program clinical team and departmental engagement, maximizing 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.
- Review and contribute to the development of protocol/study design, informed consent forms, case report forms, and other study documents/plans.
- Apply a risk-based quality management mindset, contribute to the risk management plan, and support the set up of adaptive risk monitoring systems with the study team as applicable.
- Work with functional leads and sponsors to identify data-related issues and risks to clinical activities, assist Clinical Leads in the development of mitigation plans to minimize risk.
- Support the Project Manager, regional Clinical Leads, and/or 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 ensuring pre-approval of these tasks by the Project Manager and Sponsor, as required.
- 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, with at least 4 years of clinical monitoring (or related) experience 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.
- Premier Research is a community of people that truly care about one another, our clients, and 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.
- We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
