Clinical Trial Manager II, CVRM - IQB, Brazil at IQVIA

São Paulo, State of São Paulo, Brazil

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical ResearchIndustries

Requirements

Bachelor's Degree in health care or other scientific discipline required
Requires 5 years clinical research/monitoring experience or equivalent combination of education, training and experience
Requires basic knowledge of Project management practices and terminology
Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Requires broad protocol knowledge and therapeutic knowledge
Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates
Requires understanding of project finances
Knowledge of clinical trials - Knowledge of clinical trial conduct in addition to 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

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 through 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
Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work
Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management
Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements
Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings
Conduct regular team meetings and communicate appropriately to achieve objectives
Support professional development by providing feedback to clinical team line managers on performance relative to project tasks
May contribute to the development of the clinical delivery strategy for proposals. Participate in bid defense preparations and meetings. Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership
May mentor and coach new peers as they assimilate into this role
May work as a primary Clinical Lead alongside other Clinical Leads to deliver large, global trials
May attend site visits as applicable in support of project delivery

Skills

Key technologies and capabilities for this role

ICH-GCPSOPsClinical Trial ManagementRecruitment StrategiesRisk MitigationQuality AssuranceStakeholder ManagementProject FinancesEAC Management

Questions & Answers

Common questions about this position

What is the salary for the Clinical Trial Manager II position?

This information is not specified in the job description.

Is this Clinical Trial Manager II role remote or office-based?

This information is not specified in the job description.

What qualifications are required for this Clinical Trial Manager II role?

A Bachelor's Degree is required for this position.

What does the team structure look like for the Clinical Lead role?

The Clinical Lead is a member of the core project team, leads clinical teams, and may work alongside other Clinical Leads to deliver large global trials while managing resourcing and talent planning.

What makes a strong candidate for the Clinical Trial Manager II position?

Strong candidates will have experience ensuring clinical delivery in compliance with regulatory requirements, managing recruitment targets and clinical risks, leading clinical teams, and contributing to project finances and stakeholder management.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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