Clinical Operations Lead — People & Quality

Regulatory Jobs; Durham (NC); Sur place; USD 87 000 - 216 000; Plein temps

Résumé du poste

IQVIA seeks a seasoned professional to lead clinical operations, manage staff, and ensure adherence to GCP and ICH guidelines. The role includes onboarding, training oversight, and resource allocation across clinical studies.

You will drive quality by reviewing work, addressing risks, and coordinating with cross-functional teams to meet deadlines and maintain service excellence. Strong leadership and communication are essential.

Qualifications

• Bachelor's Degree in scientific discipline or healthcare preferred.
• Prior clinical trial experience including experience in a management/leadership capacity or equivalent combination of education, training and experience.
• In-depth knowledge of applicable clinical research regulatory requirements (GCP and ICH).
• Strong leadership skills.
• Computer skills including proficiency in Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills including good command of English.
• Excellent organizational and problem solving skills.
• Effective time management and ability to manage competing priorities.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Responsabilités

• Manage staff in accordance with organization policies and regulations; plan, assign, and direct work; assess performance and guide development.
• Participate in hiring: candidate review and interviewing; ensure onboarding and training.
• Ensure staff have materials, access, and training to complete responsibilities; oversee training plans and SOP reviews.
• Allocate resources to clinical research projects by assigning staff based on experience and training.
• Manage quality of staff's clinical work through regular review of outcomes.
• Identify quality risks and create corrective action plans to address deficiencies.
• Monitor workload and quality metrics, and report findings to clinical operations management.
• Collaborate with clinical teams and leadership to address project challenges and maintain service quality.
• Participate in organizational quality or process improvement initiatives.

Connaissances

Leadership

Clinical trials

Regulatory knowledge

GCP/ICH knowledge

English communication

Time management

Problem solving

Team collaboration

Relationship building

Formation

Bachelor's degree in science or healthcare

Outils

Microsoft Word

Microsoft Excel

PowerPoint

Description du poste

IQVIA seeks a seasoned professional to lead clinical operations, manage staff, and ensure adherence to GCP and ICH guidelines. The role includes onboarding, training oversight, and resource allocation across clinical studies.

You will drive quality by reviewing work, addressing risks, and coordinating with cross-functional teams to meet deadlines and maintain service excellence. Strong leadership and communication are essential.