Sr Clinical Trial Manager - Cell Therapy

IQVIA; Buenos Aires; Presencial; ARS 132.725.744 - 191.714.963; Jornada completa

Descripción de la vacante

IQVIA is seeking a Senior Clinical Project Manager to lead global clinical trial delivery from start-up through closeout. You will oversee end-to-end management, ensuring regulatory compliance and alignment with customer requirements.

Responsibilities include delivering recruitment targets, managing risk, and maintaining high-quality clinical conduct under GCP/ICH with Cell Therapy experience as mandatory. This role requires collaboration across regions and functions to drive successful outcomes.

Formación

• Bachelor’s degree in health care or other scientific discipline.
• 8 years clinical research/monitoring experience.
• Minimum 3 years regional/global trial management experience in pharma or CRO.
• In-depth knowledge of GCP and ICH guidelines.
• Cell Therapy TA experience is mandatory.
• Knowledge of project finances.
• Knowledge of clinical trial conduct and regulatory requirements (ICH/GCP) and local laws.

Responsabilidades

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (GCP/ICH), protocol, customer contract, and internal SOPs.
• Accountable for meeting recruitment targets and ensuring appropriate recruitment strategies.
• Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the lifecycle.
• Ensure clinical quality delivery by identifying quality standards, planning compliance measurement, and overseeing quality issues.

Conocimientos

GCP knowledge

ICH guidelines

Clinical project management

Educación

Bachelor’s degree in health care or related science

Descripción del empleo

The Sr Clinical Project Manager provide management of a clinical trial (s) in a global level. Services/deliverables include operational oversight of assigned project(s) 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, Standard Operating Procedures (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 Health care or other scientific discipline Req
• 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 - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.

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 https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.