- Flexible Approved Time Off.
Ensures study timelines and deliverables are met by CRA staff, including, but not limited to, development of the clinical monitoring plan per the Statement of Work (SOW), evaluation of the risk-based monitoring strategy, monitoring visit frequency, monitoring visit report submission/approval timelines, study data collection timelines, and the annotated reports per the project SOW and/or Emmes SOPs. · 4+ years of experience within a services organization, ideally a pharmaceutical, biotechnology, or contract research organization. · 6+ years of experience leading teams and managing complex, cross-functional projects. · Strong analytical and critical thinking skills with a track record of sound judgment in fast-paced, deadline-driven environments. · Proven leadership capability with a coaching mindset and a consistently collaborative, supportive approach to developing others. · div>At Parexel Baltimore Unit (located in the MedStar Harbor hospital) our highly trained and skilled Physician Assistants (PA) functions under the direction and guidance of a licensed physician to ensure the safety of study participants. Participates in the review of source data and/or data listings of safety data, including adverse experiences, laboratory data, and vital signs data, as appropriate, with the clinical team, project team, sponsor, investigator, and regulatory agencies.
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