Clinical Study Manager- Oncology

IQVIA • Durham, NC

20h

About The Position

Clinical Leads are integral to clinical trial delivery, working alongside clinical teams to improve patients’ lives by bringing 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, Standard Operating Procedures, policies, and practices. The role ensures clinical delivery to customers, leads clinical teams, and partners with Project Leaders and other functional teams to meet project delivery requirements.

The position oversees assigned projects’ clinical delivery, recruitment, risk mitigation, quality, finances, stakeholder communications, resourcing, and talent planning. It guides clinical teams through operational plans and project-related training, supports milestone achievement, and reports to internal and external stakeholders. The role may also contribute to proposal strategy and bid defenses, mentor new peers, work alongside other Clinical Leads on large global trials, and attend site visits as appropriate.

Requirements

• Bachelor’s degree in healthcare or another scientific discipline.
• At least 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 the environments in which it operates.
• Understanding of project finances.
• Knowledge of clinical trial conduct and the application of 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, prioritization, and organization skills, including the ability to handle conflicting priorities.
• Attention to detail and accuracy, with a results-oriented approach to work delivery and output.
• Influencing, negotiation, judgment, and decision-making skills.
• 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 Core Competencies: Client Focus, Collaboration, Communication, Innovation, and Ownership.

Responsibilities

• Ensure assigned projects are delivered in compliance with regulatory requirements, including ICH-GCP and protocol requirements, customer requirements, and internal 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 delivery by identifying quality standards and requirements, planning compliance measurement, and monitoring and overseeing clinical quality issues.
• Manage clinical aspects of project finances, including Estimate at Completion (EAC); understand delivery scope, plan delivery, manage changes against baseline EAC, and identify additional service opportunities or out-of-scope work.
• Identify and manage internal and external project stakeholders 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 team at project level 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 relative to project tasks.
• Contribute to clinical delivery strategy for proposals and participate in bid-defense preparation and meetings as needed.
• Develop and present a Clinical Operations plan in partnership with Business Development and Project Leadership.
• Mentor and coach new peers as they assimilate into the role, as needed.
• Work as a primary Clinical Lead alongside other Clinical Leads to deliver large global trials, as needed.
• Attend site visits in support of project delivery, as applicable.

Benefits

• Health and welfare benefits may be offered, depending on the position.
• Incentive plans, bonuses, and/or other forms of compensation may be offered, depending on the position.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level