Clinical Lead

IQVIA•Durham, NC

About The Position

Clinical Leads are integral to clinical trial delivery, working with clinical teams to help bring new drugs to market faster. As a member of the core project team, the Clinical Lead is responsible for delivering clinical studies in accordance with contractual requirements, SOPs, policies, and practices. The role leads clinical teams and partners with Project Leaders and other functional teams to ensure project delivery requirements are met. The Clinical Lead oversees clinical delivery, recruitment, risk mitigation, quality, project finances, stakeholder communication, resourcing, and talent planning. The role also supports project milestones, team development, proposal and bid activities, and may mentor peers, work alongside other Clinical Leads on large global trials, or attend site visits as applicable.

Requirements

Bachelor’s degree in health care 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 its relevant operating environments.
Understanding of project finances.
Knowledge of clinical trial conduct and ability to apply ICH, GCP, and relevant local laws, regulations, and guidelines.
Strong written and verbal communication skills and good command of English.
Problem-solving skills.
Planning, time management, and prioritization skills, including the ability to handle conflicting priorities.
Attention to detail and accuracy, with a results-oriented approach to work delivery and output.
Good influencing, negotiation, judgment, and decision-making skills; effective mentoring and training skills that foster learning and knowledge sharing.
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 competencies: Client Focus, Collaboration, Communication, Innovation, and Ownership.

Responsibilities

Ensure assigned projects are delivered in compliance with regulatory, customer, and internal requirements.
Meet project recruitment targets and ensure appropriate recruitment strategies are in place.
Contribute to project risk mitigation planning and manage clinical risks throughout the project lifecycle.
Identify clinical quality standards and requirements, plan how compliance will be measured, and oversee the management of clinical quality issues.
Manage clinical aspects of project finances, including Estimate at Completion (EAC); plan clinical delivery, monitor changes against the 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 resolution management.
Collaborate with the clinical team to support milestone achievement and report to internal and external stakeholders according to project scope requirements.
Plan clinical team resourcing and talent; manage the project-level clinical 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 related to project tasks.
May contribute to clinical delivery strategy for proposals, participate in bid defense preparation and meetings, and develop and present a Clinical Operations plan with Business Development and Project Leadership.
May mentor and coach new peers as they assimilate into the role.
May serve as a primary Clinical Lead alongside other Clinical Leads on large global trials.
May attend site visits as applicable to support project delivery.