Global Study Manager – Single Sponsor Dedicated (EMEA)
- Company: IQVIA
- Location: Bloemfontein, South Africa
- Employment Type: Full-time
- Work Arrangement: Home-based
- Job Reference: R1534243
- Closing Date: Not specified
Job Overview
IQVIA is seeking a Global Study Manager to support the delivery of clinical studies within BioPharmaceuticals Clinical Operations. The successful candidate will help manage clinical studies from protocol development and study set-up through maintenance, close-out, Clinical Study Report development and study archiving.
The role involves working closely with internal teams, clients, CROs and external service providers to ensure clinical studies are delivered on time, within budget and according to required quality standards.
Key Responsibilities
- Support the preparation of study documents, including informed consent forms and clinical study agreements.
- Coordinate with internal departments, CROs and external service providers to support efficient study delivery.
- Assist with planning and conducting investigator and monitor meetings.
- Coordinate the supply of investigational products and study materials.
- Identify study risks and issues and assist with developing mitigation and action plans.
- Ensure study documents are complete, accurate and maintained in the Trial Master File.
- Support budget management and external service provider invoice reconciliation.
- Ensure compliance with clinical processes, SOPs, quality requirements and ICH/GCP guidelines.
- Support overall clinical project management as delegated by the Global Study Director or Global Study Associate Director.
- Assist with the oversight and management of CRO Project Managers on outsourced studies.
- Contribute to process improvement and other non-drug project initiatives.
Minimum Requirements
- University degree or equivalent, preferably in:
- Medical Sciences
- Biological Sciences
- Clinical Research
- A related discipline.
- At least 3 years’ relevant experience in the pharmaceutical industry, a similar organisation or an academic environment.
- Knowledge of clinical development and the drug development process.
- Knowledge of different phases of clinical development and therapy areas.
- Excellent knowledge of international ICH/GCP guidelines.
- Strong communication and relationship-building skills.
- Experience managing external service providers.
- Good project management skills.
- Ability to work collaboratively and independently.
- Demonstrated leadership skills.
- Advanced computer proficiency.
- Excellent written and verbal English communication skills.
Ideal Candidate
The ideal candidate is an experienced clinical research professional with strong project management, communication and stakeholder management skills. They should be able to work independently while collaborating effectively with global teams, CROs and external partners.