Clinical Lead

IQVIA•Durham, NC

4d•$93,100 - $232,800

About The Position

Clinical Leads are integral to clinical trial delivery, working alongside clinical teams to help bring new drugs to market faster. As members of core project teams, they are responsible for clinical delivery of studies in accordance with contractual requirements, Standard Operating Procedures (SOPs), policies, and practices. They ensure delivery to customers, lead clinical teams, and partner with Project Leaders and other functional teams to meet project requirements. The role may include contributing to proposal strategy and bid defenses, mentoring new peers, supporting large global trials alongside other Clinical Leads, and attending site visits as applicable.

Requirements

Bachelor’s degree in healthcare or another scientific discipline.
Five years of clinical research or monitoring experience, or an equivalent combination of education, training, and experience.
Basic knowledge of project management practices and terminology.
Good knowledge of applicable clinical research regulatory requirements, including GCP and ICH guidelines.
Broad protocol and therapeutic knowledge.
Good understanding of the clinical research industry and relevant operating environments.
Understanding of project finances.
Knowledge of clinical trial conduct and ability to apply applicable ICH, GCP, local laws, regulations, and guidelines.
Strong written and verbal communication skills, including good command of English.
Problem-solving skills.
Planning, time-management, and prioritization skills, including ability to handle conflicting priorities.
Attention to detail and accuracy, with a results-oriented approach to work delivery and output.
Influencing and negotiation skills, sound judgment and decision-making, and effective mentoring and training skills.
Good software and computer skills, including Microsoft Word, Excel, and PowerPoint.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Ability to work across geographies with awareness and understanding of cultural differences.
Ability to influence without authority.
Ability to demonstrate IQVIA core competencies: Client Focus, Collaboration, Communication, Innovation, and Ownership.

Responsibilities

Ensure assigned projects are clinically delivered in compliance with regulatory, customer, and internal requirements, including ICH-GCP, protocols, contracts, policies, SOPs, and project plans.
Meet project recruitment targets and ensure appropriate recruitment strategies are in place.
Contribute to project risk mitigation plans and manage clinical risks throughout the project lifecycle.
Ensure clinical quality by identifying quality standards and requirements, planning compliance measurement, and monitoring and overseeing clinical quality issues.
Manage clinical project finances, including Estimate at Completion (EAC); understand delivery scope, create delivery plans, monitor changes against baseline EAC, and identify additional service opportunities or out-of-scope work.
Identify the project’s clinical stakeholders and manage internal and external relationships through effective communication and issue resolution.
Collaborate with the clinical team to support milestones and report to internal and external stakeholders according to project scope requirements.
Plan clinical team resourcing and talent; manage the project-level team through operational plans, guidance, and project-related training.
Conduct regular team meetings and communicate appropriately to achieve objectives.
Support professional development by providing clinical team line managers with feedback on performance in project tasks.
May contribute to clinical delivery strategy for proposals, participate in bid-defense preparation and meetings, and develop and present the Clinical Operations plan with Business Development and Project Leadership.
May mentor and coach new peers.
May serve as a primary Clinical Lead alongside other Clinical Leads on large global trials.
May attend site visits in support of project delivery.