Sr Clinical Trial Manager - Global Studies

IQVIA Argentina; Santiago; Presencial; CLP 103.189.000 - 140.713.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a Sr Clinical Project Manager to lead global clinical trials from start-up through closeout. You will oversee end-to-end management, ensure compliance with GCP/ICH, and manage recruitment strategies to hit targets within a multinational framework.

The role requires extensive trial management experience and strong knowledge of regulatory requirements. IQVIA emphasizes integrity and rigorous processes across its global clinical research services.

Formación

• 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.
• Minumun 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.
• Nice to have Cell Therapy/Hemayology TA experience.
• 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. ICH and GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.

Responsabilidades

• 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 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.

Conocimientos

GCP knowledge

ICH guidelines

Clinical trial management experience

Budget/finances understanding

Cell Therapy/Hematherapy TA experience

Educación

Bachelor's Degree Health care or other scientific discipline

Minimum 3 years regional/global trial management experience

Descripción del empleo

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.
• Minumun 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.
• Nice to have Cell Therapy/Hemayology TA experience.
• 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.

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.

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.