Sr Clinical Trial Manager - Global Studies

IQVIA; Santiago; Presencial; CLP 83.955.223 - 121.268.656; Jornada completa

Descripción de la vacante

IQVIA seeks a Sr Clinical Project Manager to lead global trials from start-up through closeout, ensuring delivery on time and within budget with cross-regional oversight.

The role requires 8+ years in clinical research/monitoring, deep GCP/ICH knowledge, and explicit Cell Therapy TA experience, plus strong financial oversight for projects.

Formación

• Knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Ability to apply regulatory requirements to trial conduct.
• Experience in budgeting and financial tracking for projects.

Responsabilidades

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements and contracts.
• Accountable for meeting recruitment targets and implementing recruitment strategies.
• Contribute to development of risk mitigation plans and manage clinical risks throughout the project lifecycle.
• Ensure quality delivery by monitoring compliance with quality standards and addressing quality issues.

Conocimientos

GCP knowledge

ICH guidelines

Regulatory compliance

Project finances

Educación

Bachelor's degree in Health care or other scientific discipline

Descripción del empleo

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.