Regulatory and Start Up Manager, Sponsor Dedicated

Job Overview
Manages a single department or work unit responsible for site activation. Sets goals and objectives for team members for achievement of short-term operational or tactical results.      

Essential Functions
• Manages staff's delivery of site activation activities 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 employee, and addressing employee relations issues and resolving problems.
• Participate in the selection process 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, as required, in the allocation of resources to clinical research projects by assigning staff based on their experience and training.
• Manage the quality of assigned staff's 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.
• Responsible for leading moderate improvements of processes, systems or products to enhance performance of the job area.
• Problems faced are difficult, and may require understanding of broader set of issues.
• Understands and demonstrates management approaches such as work scheduling, prioritizing , coaching and process execution.
• Good knowledge and ability to apply GCP/ICH and applicable regulatory guidelines and applicable regulatory guidelines.

Qualifications
• Bachelor's Degree Scientific discipline or health care preferred.

• Experience and strong knowledge in budgeting, contract review, and project financial management are preferred.

• A minimum of 5–6 years of experience in start-up or site activation is required.

• Experience as an RSU Lead or Site Activation Lead is required.

• Experience as a CRA Manager, Clinical Lead, Project Lead, Start-up Manager, Site Activation Manager, or Regulatory Affairs (RA) specialist is preferred.

• Excellent written and verbal communication skills in English are required.

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.