Mgr, Reg & Start Up (FSP)

Manager, Regulatory & Start Up – Sponsor Dedicated

Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. Sets goals and objectives for team members for achievement of short-term operational or tactical results.

You will:

• Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines. Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required. Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
• Manages staff's delivery of RSU team in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, assessing performance, and guiding professional development 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.
• Participate, as required, in the allocation of resources to clinical research projects by assigning staff based on their experience and training.
• Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.
• Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.

What do you need to have?

• Bachelor's Degree Scientific discipline or health care preferred.
• Requires a minimum of 5 -7 years of prior relevant experience: Submissions to regulatory entity and ethics committees, local regulatory processes, knowledge and use of DIGIPRiS, knowledge and handling of ICFs, preparation of risk analyses and projections, interaction with and knowledge of the local Ministry of Health.
• People Management - Proven ability to manage a team and work alongside others in a global environment to deliver results whilst meeting quality and timeline metrics.
• Fluent English (read, spoken, and written)
• Provides others with a clear direction, delegates work appropriately and fairly, motivates, and empowers others, monitors/manages performance and provides feedback and coaching.

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.