Global Clinical Delivery Lead

Regulatory Jobs; Durham (NC); On-site; USD 93,000 - 233,000; Full time

Job summary

IQVIA is seeking a Clinical Lead to drive clinical delivery across global trials, ensuring adherence to ICH/GCP and project plans. You will lead clinical teams, manage recruitment and risk, and collaborate with stakeholders to meet contractual milestones.

Responsibilities include coordinating with Project Leaders, monitoring finances, and mentoring peers. Strong communication and leadership are essential in this senior role.

Qualifications

• 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. ICH and GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct.
• Communication - Strong written and verbal communication skills including good command of English language.
• Problem solving - Problem solving skills.
• Organization - Planning, time management and prioritization skills.
• Prioritization - Ability to handle conflicting priorities.
• Quality - Attention to detail and accuracy in work. Results-oriented approach to work delivery and output.
• Leadership - Good influencing and negotiation skills. Good judgment and decision-making skills. Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
• IT skills - Good software and computer skills, including Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
• Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences.
• Effective communication - Ability to influence without authority.
• IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).

Responsibilities

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (ICH-GCP, protocol), customer requirements (contract), and internal requirements (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 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

Clinical delivery

ICH/GCP

Project management

Regulatory knowledge

Budgeting

Leadership

Communication

Problem solving

Team mentoring

Cross-cultural collaboration

Education

Bachelor's degree in health care or other scientific discipline

Tools

Microsoft Word

Excel

PowerPoint

Job description

IQVIA is seeking a Clinical Lead to drive clinical delivery across global trials, ensuring adherence to ICH/GCP and project plans. You will lead clinical teams, manage recruitment and risk, and collaborate with stakeholders to meet contractual milestones.

Responsibilities include coordinating with Project Leaders, monitoring finances, and mentoring peers. Strong communication and leadership are essential in this senior role.