Regulatory And Start Up Manager - Mena

Iqvia Argentina; Gauteng; Remote; ZAR 600,000 - 900,000; Full time

Job summary

A leading global provider of clinical research services is seeking a Site Activation Manager in South Africa. This home-based role involves overseeing site activation, maintaining compliance with regulatory standards, and collaborating with various teams. Ideal candidates will possess significant experience in clinical environments and strong leadership skills to manage projects effectively.

Qualifications

• Minimum of 7 years' experience in a scientific or clinical environment.
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
• Experience in financial management in clinical studies.

Responsibilities

• Oversee the execution of Site Activation and Maintenance for assigned projects.
• Ensure collaboration across Regulatory & Site Activation teams.
• Manage operational strategies for maintaining study approvals.

Skills

Leadership

Organizational Skills

Decision-Making

Financial Management

Education

Bachelor's Degree in Life Sciences

Job description

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, scope of work, budget, and resources.

Home-based role, requiring yearly travel for bid-defense meetings and study kick-off meetings.

Essential Functions

1. Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects, ensuring adherence to project timelines and RSU site activation strategy.
2. Develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan, resolving project-related issues as needed.
3. Ensure collaboration across Regulatory & Site Activation teams, including communication with regions and countries, to deliver project scope in compliance with the RSU Management Plan.
4. Create and review technical and administrative documentation to support business development and study initiation and maintenance.
5. Provide regulatory and technical scientific support to facilitate clinical trial processes, ensuring compliance with regulatory requirements.
6. Guide and oversee multi-regional and multi-protocol programs during start-up and maintenance phases.
7. Determine regulatory strategies and expectations for submissions and authorizations.
8. Identify regulatory challenges and develop practical solutions to support bid processes and site activation plans.
9. Assess regulatory landscape and contribute to the collection and analysis of regulatory intelligence.
10. Manage operational strategies for maintaining study approvals, including contract review and negotiations.
11. Collaborate with Quality Management to uphold standards during site activation and maintenance.
12. Mentor and coach colleagues as needed.
13. Maintain accurate internal systems, databases, and project plans.
14. Potentially lead in developing relationships with preferred IQVIA customers.
15. Deliver presentations and training as required.
16. Participate in monthly study budget planning and reviews.

Qualifications

• Bachelor's Degree in Life Sciences
• Minimum of 7 years' experience in a scientific or clinical environment, including international roles
• Understanding of the regulated clinical trial environment and drug development process
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements
• Leadership skills with the ability to motivate and mentor
• Excellent organizational, planning, and decision-making skills
• Financial management experience in clinical studies

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence, dedicated to accelerating medical development and improving patient outcomes worldwide.