Clinical Operations Lead

2 semanas atrás

Colômbia, Brasil IQVIA Tempo inteiro

Clinical Operations Lead, RWE

The COL leads the execution of the Site & Patient Services (SPS) components of Real World Late Phase Research (RLWPR) studies by applying clinical research expertise, exceptional decision-making skills and innovative approaches to problem solving. Proactively set project goals and tangible expectations for SPS project team members

Essential Functions:

  • Oversee the delivery of Site Management project tasks, providing advice and guidance to achieve high performance and quality project deliverables.
  • Ensure overall project efficiency and adherence to project timelines and financial goals;
    report metrics and out of scope activities.
  • Develop, implement and maintain the Site Recruitment, SPS Operations and SPS Risk Management Plan within the agreed project strategy.
  • Collaborate with other functional groups within the company such as data management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.
  • Manage and follow study activities through ongoing tracking and review of study progress. Provide input and report progress to appropriate SPS management and project management leaders.
  • Act as the first line of escalation for site management questions and issues on assigned projects.
  • Lead preparation for in-house audits and in creation of Corrective Action Plans (CAPAs).
  • Develop and deliver presentations/training to clients, colleagues and professional bodies, as required.

Requirements:

  • Bachelor Degree preferably in a life sciences discipline, and 4 years of monitoring experience, project leadership experience;
    or equivalent combination of education, training and experience.
  • Previous experience as Study Lead and SSU.
  • In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements;
    i.E., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Skill in understanding and executing complex study designs.
  • Strong written and verbal communication skills including good command of English language.
  • Demonstrated team leadership and mentoring skills.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at />//jobs.Iqvia.Com

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