Sr Clinical Trial Manager - Global Studies

IQVIA; Bogotá; On-site; COP 120,000,000 - 180,000,000; Full time

Job summary

IQVIA is seeking a Sr Clinical Project Manager to lead management of clinical trials at a global level, from start-up through closeout. The role focuses on delivering compliant clinical trials, managing recruitment targets, and mitigating risks across the project lifecycle.

The position requires strong knowledge of GCP/ICH guidelines, 8+ years in clinical research, and 3+ years regional/global trial management experience within pharma or CRO settings. HQ relocation not specified.

Qualifications

• Bachelor's degree in health care or a related scientific field.
• 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 GCP and ICH guidelines.
• Nice to have Cell Therapy/Hematology TA experience.
• Knowledge of project finances.
• Knowledge of clinical trials conduct and applicable regulatory requirements (ICH/GCP and local laws).

Responsibilities

• 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 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, planning how compliance will be measured, and monitoring quality issues.

Skills

Trial management

GCP/ICH knowledge

Budgeting knowledge

Regulatory compliance

Clinical research experience

Team collaboration

Education

Bachelor's degree in health care or related

Job description

Mexico City, Mexico

Santiago, Chile

Panama City, Panama

Buenos Aires, Argentina

San Jose, Costa Rica

São Paulo, Brazil

Bogota, Colombia

Full time

R1558569

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.
• 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.

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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