Sr Clinical Trial Manager - Global Studies

IQVIA; Municipio de Esquel; Presencial; ARS 300.000 - 420.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a Senior Clinical Project Manager to lead global trials from initiation through closeout, providing operational oversight and end-to-end project management. You will ensure delivery in compliance with ICH/GCP, protocol and contracts, drive recruitment strategies, and monitor quality across the trial lifecycle.

This role requires a health care or life science degree, 8 years of clinical research experience, and 3+ years in regional/global trial management; Cell Therapy TA

Formación

• Bachelor's degree in health care or other scientific discipline.
• 8 years clinical research/monitoring experience or equivalent.
• Minimum 3 years of regional/global trial management experience in the pharmaceutical industry or CRO.
• In-depth knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Specific Cell Therapy TA experience (mandatory).
• Knowledge of clinical trials - applying regulatory requirements (ICH, GCP, local laws).

Responsabilidades

• Provide management of a clinical trial(s) at the global level from start-up through closeout.
• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (ICH-GCP, protocol), customer requirements (contract), and internal requirements (policies, SOPs, project plans).
• Accountable for achieving recruitment targets and ensuring recruitment strategies are in place.
• Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project lifecycle.
• Ensure clinical quality delivery by identifying quality standards/requirements and monitoring quality issues.

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.