Sr Clinical Trial Manager - Global Studies

IQVIA; São Paulo; Presencial; BRL 150 000 - 190 000; Tempo integral

Resumo da oferta

IQVIA seeks a Sr Clinical Project Manager to oversee global clinical trials from start-up through closeout. The role ensures regulatory compliance (ICH/GCP), contract adherence, and internal policy alignment.

You will drive recruitment strategies and monitor project risks and quality throughout the lifecycle. Ideal candidates bring extensive clinical research/monitoring experience, deep GCP/ICH knowledge, and specific cell therapy TA expertise, plus strong financial acumen.

Qualificações

• Requires in-depth knowledge of GCP and ICH guidelines.
• Experience with cell therapy TA is mandatory.
• Experience in regional/global trial management.
• Strong understanding of project finances.

Responsabilidades

• Manage clinical trial delivery at global level from start-up to closeout.
• Ensure regulatory compliance (ICH/GCP), contracts, and internal SOPs.
• Accountable for recruitment targets and recruitment strategies.
• Develop and monitor risk mitigation and quality management plans.

Formação académica

Bachelor's Degree in Health care or other scientific discipline

Descrição da oferta de emprego

The Sr Clinical Project Manager provides management of a clinical trial (s) at the global level. Services/deliverables include operational oversight of assigned projects at the global level for end-to-end project management from start-up through to closeout activities.

Tasks & Responsibilities

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, SOPs, project plans).
• Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.
• Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project’s lifecycle.
• Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.

Essentials Requirements

• Bachelor's Degree in Health care or other scientific discipline.
• Requires 8 years clinical research/monitoring experience or equivalent combination of education, training and experience.
• Minimum 3 years of regional/global trial management experience in the pharmaceutical industry or CRO.
• Requires in-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Specific Cell Therapy TA experience (mandatory).
• Requires good knowledge of project finances.
• Knowledge of clinical trials - skill in applying applicable clinical research regulatory requirements i.e. ICH and GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.