Lead Clinical Project Manager — CMC Expert

IQVIA LLC; Durham (NC); On-site; USD 93,000 - 233,000; Full time

Job summary

IQVIA LLC is seeking a Project Lead to manage clinical study delivery, ensuring milestones, quality, and cost targets while aligning with SOPs and client expectations.

The role requires coordinating cross-functional teams across pre-clinical to regulatory, anticipating risks, and leading bid defenses. Leverage IQVIA solutions to drive operational excellence and improve patient outcomes.

Qualifications

• Bachelor's Degree Life sciences or related field required.
• 8-10 years experience in the biopharmaceutical industry with experience in supporting product development teams.
• Strong understanding of drug development strategies across all critical product development disciplines.
• Advanced knowledge of job area, and broad knowledge of other related job areas.
• Knowledge of clinical trials and regulatory requirements (ICH GCP).
• Strong written and verbal communication skills in English; strong presentation skills.

Responsibilities

• Collaborate with other functional groups to support milestone achievement and manage study issues.
• Build robust plans, anticipate risks and respond to deviations.
• Coordinate outsourced development activities with CDMOs and external partners.
• Develop integrated study management plans with the core project team.
• Ensure execution of clinical studies per contract while optimizing speed, quality and cost.
• Forecast and identify opportunities to accelerate activities and revenue.

Skills

Cross-functional collaboration

Leadership

Communication

Problem solving

Organization

Prioritization

Quality

IT skills

Education

Bachelor's Degree Life sciences or related field

Tools

MS Office

Job description

IQVIA LLC is seeking a Project Lead to manage clinical study delivery, ensuring milestones, quality, and cost targets while aligning with SOPs and client expectations.

The role requires coordinating cross-functional teams across pre-clinical to regulatory, anticipating risks, and leading bid defenses. Leverage IQVIA solutions to drive operational excellence and improve patient outcomes.