Clinical Trial Manager II, IQVIA Biotech

IQVIA•Columbia, MD

About The Position

The Clinical Trial Manager II (described in the posting as a Clinical Lead) is a member of the core project team responsible for clinical delivery of clinical studies. The role ensures projects meet contractual, regulatory, customer, and internal requirements, and leads clinical teams in partnership with Project Leaders and other functional teams. The position works to deliver studies in accordance with applicable Standard Operating Procedures, policies, and practices. The Clinical Lead manages clinical delivery across the project lifecycle, including recruitment, risk mitigation, quality, project finances, stakeholder communication, resourcing, and team development. The role may also contribute to proposal and bid-defense activities, mentor peers, support large global trials alongside other Clinical Leads, and attend site visits when applicable.

Requirements

Bachelor’s degree in health care or another scientific discipline.
At least 5 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 the environments in which it operates.
Understanding of project finances.
Knowledge of clinical trial conduct and ability to apply ICH, GCP, and relevant local laws, regulations, and guidelines to clinical trials.
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, good judgment and decision-making, and 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 clinical delivery of assigned projects complies 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 planning and manage clinical risks throughout the project lifecycle.
Identify clinical quality standards and requirements, plan how compliance will be measured, and monitor and oversee the management of clinical quality issues.
Manage clinical aspects of project finances, including Estimate at Completion (EAC); understand delivery scope, create delivery plans, monitor changes against the baseline EAC, and identify additional service opportunities or out-of-scope work.
Identify project 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 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 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 strategies for proposals, participate in bid-defense preparation and meetings, and develop and present Clinical Operations plans with Business Development and Project Leadership.
May mentor and coach new peers entering the role.
May serve as a primary Clinical Lead alongside other Clinical Leads to deliver large global trials.
May attend site visits as applicable to support project delivery.