Assoc Clinical Lead Director

IQVIA•Durham, NC

About The Position

Associate Clinical Lead Directors are integral to clinical trial delivery, leading and working alongside clinical teams to help bring new drugs to market faster. As a member of the core project team, this role is responsible for clinical delivery of full-service, large, multi-regional studies or programs of studies in accordance with contractual requirements, SOPs, policies, and practices. The Associate Clinical Lead Director ensures delivery to customers and partners with Project Leaders and other functional teams to meet project requirements. The role provides strategic clinical leadership across large global trials, including setting clinical strategies, managing recruitment and clinical risks, ensuring quality and regulatory compliance, overseeing clinical project finances, and coordinating stakeholders and clinical teams. It also supports business proposals, bid defenses, team development, and departmental or corporate initiatives. Site visits may be attended as applicable to support project delivery.

Requirements

Bachelor’s degree in a health care or other scientific discipline.
At least 10 years of clinical research or monitoring experience, or an equivalent combination of education, training, and experience.
In-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Consolidated knowledge of project management practices and terminology.
High proficiency in using systems and technology to achieve work objectives.
Good knowledge of project finances.
Knowledge of clinical trial conduct and ability to apply clinical research regulatory requirements, including ICH, GCP, and relevant 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 the ability to handle conflicting priorities.
Attention to detail and accuracy; results-oriented approach to work delivery and output.
Good influencing, negotiation, judgment, and decision-making skills.
Effective mentoring and training skills, including fostering learning and knowledge sharing.
Good software and computer skills, including Microsoft Word, Excel, and PowerPoint.
Ability to establish and maintain effective working relationships.
Ability to work across geographies with awareness and understanding of cultural differences.
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.
Set and develop clinical strategies to achieve project goals.
Identify clinical quality standards and requirements, plan how compliance will be measured, and monitor and oversee clinical quality issues.
Manage clinical aspects of project finances, including Estimate at Completion (EAC); plan clinical delivery, manage changes against the baseline EAC, and identify additional service opportunities or out-of-scope work.
Serve as the primary Clinical Lead alongside other Clinical Leads for large global trials.
Identify project clinical stakeholders and manage internal and external relationships through effective communication and resolution management.
Collaborate with the clinical team to support milestones and report to internal and external stakeholders as required by project scope.
Plan clinical team resourcing and talent; manage the project-level clinical team through operational plans, guidance, and project-related training.
Conduct team meetings and communicate appropriately to achieve objectives.
Provide feedback to clinical team line managers about team members’ performance on project tasks to support professional development.
Contribute to clinical delivery strategies for business proposals, participate in bid-defense preparations and meetings, and develop and present Clinical Operation Plans with Business Development and Project Leadership.
Mentor and coach peers who are new to clinical lead roles.
May act as a departmental cross-functional liaison or change agent.
May attend site visits as applicable to support project delivery.
May participate in, champion, and adopt functional or corporate initiatives, changes, or special project assignments.