Sr Clinical Trial Manager - Global Studies Pcd

IQVIA Inc; São Paulo; On-site; BRL 350,000 - 550,000; Full time

Job summary

IQVIA is seeking a Senior Clinical Project Manager to oversee global trials from start-up through closeout, delivering on time, in scope and within budget while ensuring regulatory compliance and client satisfaction.

The role requires 8+ years in clinical research/monitoring with 3+ years in regional/global trial management, deep GCP/ICH knowledge, and strong financial acumen; opportunities span diverse programs and global collaboration.

Qualifications

• Bachelor's degree in Health care or other scientific discipline.
• 8 years clinical research/monitoring experience or equivalent.
• Min 3 years regional/global trial management experience.
• In-depth knowledge of GCP and ICH guidelines.
• Nice to have Cell Therapy/Hemayology TA experience.
• Knowledge of project finances.
• Knowledge of regulatory requirements in clinical trials.

Responsibilities

• Provide management of a clinical trial(s) at global level with end-to-end oversight from start-up to closeout.
• Ensure clinical delivery compliant with ICH-GCP, protocol, contract, and internal policies.
• Achieve recruitment targets and execute recruitment strategies.
• Contribute to risk mitigation planning and manage clinical risks throughout the lifecycle.

Skills

GCP/ICH knowledge

Regulatory compliance

Education

Bachelor's degree in Health care or related field

Job description

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.comIQVIA 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.

Vaga Exclusiva para Pessoa com deficiência (PCD)