Regulatory And Start Up Manager - Imeta

Iqvia; Gauteng; Remote; ZAR 600 000 - 800 000; Full time

Job summary

A leading global provider of clinical research services seeks a professional to manage site activation and regulatory activities for clinical trials in South Africa. The role involves overseeing project execution, developing management plans, and ensuring compliance with regulatory requirements. Ideal candidates will have a strong background in life sciences and project management, along with excellent communication skills.

Qualifications

• Experience in clinical trials and regulatory processes is essential.
• Strong understanding of project management principles.
• Ability to mentor and coach colleagues.

Responsibilities

• Oversee execution of site activation and maintenance for assigned projects.
• Develop and maintain management plans according to project strategy.
• Provide regulatory and technical support for clinical trials.

Skills

Regulatory strategy

Project management

Communication

Problem-solving

Education

Degree in life sciences or related field

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, oversight of the scope of work, 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 enabling compliance with regulatory requirements.
6. Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
7. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
8. Identify regulatory complexities and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
9. Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis, and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
10. Execute operational strategy/expectations for maintenance of clinical study approvals, authorizations, and review/negotiation of contracts and essential documents.
11. Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).

Mentor and coach colleagues as required.

Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines, and project plans with project-specific information.

May take a lead role in developing long-standing relationships with preferred IQVIA customers.

Deliver presentations/training to clients, colleagues, and professional bodies, as required.

May be involved in activities related to 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 help improve patient outcomes and population health worldwide.