Assoc Clinical Lead Director

IQVIA•Durham, NC

9d•$106,100 - $295,500

About The Position

The Associate Clinical Lead Director is an integral member of clinical trial delivery and the core project team, leading and working alongside clinical teams to help bring new drugs to market faster. This role is responsible for clinical delivery of full-service, large, multi-regional studies or a program of studies, meeting contractual requirements and following applicable 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 leads clinical strategy, quality, risk management, recruitment, project finances, resourcing, and stakeholder communication. It also supports business proposals and bid defenses, develops Clinical Operation Plans, mentors peers, and may serve as a cross-functional liaison or change agent. Site visits and participation in functional or corporate initiatives may be required as applicable.

Requirements

Bachelor’s degree in healthcare or another 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 applicable 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 and negotiation skills, judgment, and decision-making skills.
Effective mentoring and training skills, including fostering learning and knowledge sharing.
Good software and computer skills, including Microsoft Office applications such as 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 delivered in compliance with regulatory, customer, and internal requirements, including ICH-GCP, protocols, contracts, policies, SOPs, and project plans.
Be accountable for meeting project recruitment targets and ensuring appropriate recruitment strategies are in place.
Contribute to project risk mitigation plans and manage clinical risks throughout the project lifecycle.
Develop clinical strategies and work toward realizing clinical project goals.
Ensure clinical quality delivery by defining quality requirements, planning compliance measurement, and overseeing clinical quality issues.
Manage clinical aspects of project finances, including Estimate at Completion (EAC); plan delivery, monitor changes against the baseline, and identify additional service opportunities or out-of-scope work.
Work as the primary Clinical Lead, alongside other Clinical Leads, to deliver large global trials.
Identify the project’s clinical stakeholders and manage internal and external relationships through effective communication and resolution management.
Collaborate with the clinical team to achieve milestones and report to internal and external stakeholders as required by project scope.
Plan clinical team resourcing and talent; lead the project-level team through operational plans, guidance, and project-related training.
Conduct regular team meetings and communicate to achieve project objectives.
Provide feedback to clinical team line managers on team members’ performance relative to project tasks.
Contribute to clinical delivery strategies for business proposals; participate in bid-defense preparation and meetings; 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 in support of project delivery.
May participate in, champion, and adopt functional or corporate initiatives, changes, and special project assignments.