• 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 experience is required

• 4 or more years of previous Clinical Oversight/Trial Management experience, global experience valued

• Rare disease study experience is required, with preference for additional Cell & Gene Therapy experience

• Experience with presenting at bid defense meetings highly prioritized

• Experience with study start up-related activities for site activation preferred