Clinical Lead III

Clinical Lead III

Premier Research

Remote, Bulgaria

What you'll be doing:

• Acts as a leader driving global study and/or program clinical team and departmental engagement, maximizes the efficiencies of the clinical team across studies/program;
• 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.

What we are searching for:

• Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field; or equivalent work experience;
• 9 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;
• 3 or more years of previous Clinical Oversight experience or equivalent), with priority for Neuroscience studies;
• 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.

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