Clinical Lead at IQVIA

Durham, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

Bachelor's Degree in health care or other scientific discipline
10 years clinical research/monitoring experience or equivalent combination of education, training, and experience
Experience in multiple therapeutic areas including oncology, immunology, hepatology, infectious diseases, inflammation, idiopathic pulmonary fibrosis, and cardiovascular indications
Knowledge of Project management practices and terminology
Good knowledge of applicable clinical research regulatory requirements (ICH-GCP and ICH guidelines)
Broad protocol knowledge and therapeutic knowledge
Good understanding of Clinical Research industry (drug/device/technology/etc.) and relevant environments
Understanding of project finances
Knowledge of clinical trials conduct and skill in applying applicable clinical research regulatory requirements

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)
Meet projects’ recruitment targets and ensure 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 compliance measurement, monitoring, and overseeing management of clinical quality issues
Manage clinical aspects of Project Finances including Estimate at Completion (EAC); understand scope of clinical delivery, create plans, monitor and manage changes against baseline EAC, and identify additional service opportunities or out of scope work
Identify clinical stakeholder landscape and manage internal and external stakeholders through effective communication and resolution management
Collaborate with the clinical team to support milestone achievements and report to internal and external stakeholders as per project scope requirements
Handle Resourcing and Talent Planning of the clinical team
Manage the clinical team at project level to deliver the project through high-quality operational plans, guidance, project-related trainings, regular team meetings, and appropriate communication
Support professional development by providing feedback to clinical team line managers on performance relative to project tasks
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
Mentor and coach new peers as they assimilate into the role
Work as a primary Clinical Lead alongside other Clinical Leads to deliver large, global trials
Attend site visits as applicable in support of project delivery

Skills

ICH-GCP

Clinical Trial Delivery

Recruitment Strategies

Risk Mitigation

Stakeholder Management

Project Finances

EAC Management

Oncology

Immunology

Hepatology

Infectious Diseases

Inflammation

Idiopathic Pulmonary Fibrosis

Cardiovascular

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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