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Senior Manager, Study Execution

2 semanas atrás

Colômbia, Brasil beBeeLeadership Tempo inteiro

Real World Late Phase Research Studies are complex projects that require exceptional leadership and problem-solving skills. As a Clinical Operations Lead, you will be responsible for overseeing the Site & Patient Services components of these studies, ensuring high-quality project deliverables and efficient project execution.

The ideal candidate will have a Bachelor Degree in a life sciences discipline and at least 4 years of monitoring experience or equivalent combination of education, training and experience. Strong written and verbal communication skills are essential, as well as good command of the English language.

You will be working with cross-functional teams to support milestone achievement and manage study issues and obstacles. Your ability to lead, mentor and motivate team members will be crucial in achieving project goals.

Key Responsibilities:

  • Oversee the delivery of Site Management project tasks and provide 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 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 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 create Corrective Action Plans (CAPAs).
  • Develop and deliver presentations/training to clients, colleagues and professional bodies as required.

Requirements:

  • Bachelor Degree in a life sciences discipline and at least 4 years of monitoring experience or equivalent combination of education, training and experience.
  • Previous experience as Study Lead and SSU is desirable.
  • Strong knowledge of clinical research regulatory requirements including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Ability to understand and execute complex study designs.
  • Strong written and verbal communication skills and good command of the 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 improve patient outcomes and population health worldwide .