Project Manager, Svs, Gbp

Datafin; Gauteng; On-site; ZAR 40 000 - 80 000; Full time

Job summary

An established industry player is seeking a dedicated professional to oversee site activation and maintenance for clinical trials. This role involves managing regulatory activities, ensuring compliance, and collaborating with cross-functional teams to deliver successful project outcomes. You will have the opportunity to contribute to innovative medical treatments that improve patient outcomes. If you're passionate about clinical research and thrive in a dynamic environment, this position offers a rewarding career path with opportunities for growth and development.

Qualifications

• Strong background in regulatory compliance and project management.
• Experience in overseeing clinical trials and site activation.

Responsibilities

• Manage site activation and maintenance for clinical studies.
• Ensure compliance with regulatory requirements and project timelines.
• Collaborate with teams to resolve project-related issues.

Skills

Project Management

Regulatory Compliance

Clinical Trials

Budget Management

Communication

Education

Bachelor's Degree in Life Sciences or related field

Certification in Project Management

Job description

Job Overview

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 oversight, budget, and resources. Home Based Opportunities for South Africa and Egypt.

Essential Functions

1. 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.
2. 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.
3. 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.
4. Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
5. Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation, and maintenance of clinical trials, whilst ensuring regulatory compliance.
6. Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phases as part of the study management team.
7. Determine regulatory strategies and expectations for submissions and necessary authorizations.
8. Identify regulatory complexities and challenges, offering practical solutions to support bid processes and site activation plan execution.
9. Assess and interpret the regulatory landscape, contributing to the collection and dissemination of regulatory intelligence to support studies and company objectives.
10. Execute operational strategies for maintaining clinical study approvals, including review and negotiation of contracts and essential documents.
11. Collaborate with Quality Management to ensure quality standards throughout site activation and maintenance.
12. Mentor and coach colleagues as required.
13. Ensure accurate maintenance of internal systems, databases, tracking tools, timelines, and project plans.
14. Potentially develop long-standing relationships with preferred IQVIA customers and deliver presentations or training as needed.
15. Participate in monthly study budget planning and reviews.

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 improve patient outcomes and population health worldwide.