Regulatory and Start Up Dedicated Line Manager (FSP)

Job Overview
Manage a team of clinical staff working in support of clinical studies to ensure projects are appropriately resourced and employees are trained and meeting project objectives.
 

Essential Functions

• Manage staff in accordance with organization’s policies and applicable regulations.
• Responsibilities include planning, assigning, and directing work, assessing performance and guiding professional development, rewarding and disciplining employees, and addressing employee relations issues and resolving problems.
• Participate in the selection for hiring new employees by conducting candidate review and participating in the interviewing process.
• Ensure that new employees are properly onboarded and trained.
• Ensure that staff has the proper materials, systems access and training to complete job responsibilities.
• Provide oversight for the execution of the training plan, SOP review and training experiences, as applicable.
• Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training.
• Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.
• Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
• Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.
• May collaborate with other clinical teams and other functional leadership to manage project related challenges and to achieve exemplary customer service.
• Participates in corporate or organizational departmental quality or process improvement initiatives.

Qualifications

• Bachelor's Degree in scientific discipline or health care 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 (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good leadership skills.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills including good command of English.
• Excellent organizational and problem-solving skills.
• Effective time management skills and ability to manage competing priorities.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.