Global Site Contracts Manager – Sponsor Dedicated x1
Position Information
- Job Title: Global Site Contracts Manager – Sponsor Dedicated
- Company: IQVIA
- Location: Bloemfontein
- Work Arrangement: Home-based (Remote)
- Employment Type: Full-time
- Reference Number: R1551898
Job Purpose
The Global Site Contracts Manager is responsible for overseeing clinical trial contracts, budgets, and site activation activities on a global scale. The role involves negotiating clinical trial agreements, ensuring regulatory compliance, managing site documentation, and serving as the primary liaison between investigative sites and sponsors.
This position supports the successful execution of clinical research projects while ensuring compliance with international regulations and sponsor requirements.
Key Responsibilities
1. Contract and Budget Management
- Prepare, review, negotiate, and manage clinical trial agreements (CTAs).
- Develop and manage clinical trial budgets and investigator grants.
- Create contract and budget templates.
- Develop contracting systems, tools, and processes.
2. Regulatory Documentation
- Manage site regulatory documentation.
- Ensure all required documents are completed and submitted on time.
- Maintain Trial Master File (TMF) documentation according to sponsor and company requirements.
3. Site Activation and Compliance
- Monitor and track site activation activities.
- Ensure compliance with:
- Regulations
- Standard Operating Procedures (SOPs)
- Work Instructions
- Project requirements
4. Stakeholder Management
- Serve as the primary contact for investigative sites and sponsors.
- Build strong relationships with external stakeholders.
- Address contractual and regulatory queries.
5. Project Management
- Establish project timelines and milestones.
- Monitor operational and financial performance.
- Track key performance metrics and provide reports.
6. Team Leadership
- Set goals and objectives for teams.
- Monitor team performance.
- Coordinate activities with regional and global managers.
7. Strategic Planning
- Contribute to global site activation planning.
- Support proposal development processes.
- Develop contracting strategies for complex projects.
Minimum Qualifications
Education
- Bachelor’s Degree in:
- Scientific discipline
- Healthcare-related field
Experience
- 3–5 years of relevant experience in:
- Clinical research
- Site contracts
- Regulatory affairs
- Clinical trial management
Required Knowledge and Skills
Technical Knowledge
- Thorough understanding of:
- Clinical trial regulations
- Drug development processes
- Site activation procedures
- Regulatory documentation
- Clinical trial agreements (CTAs)
- Trial Master Files (TMF)
Key Skills
- Contract negotiation
- Budget management
- Communication and stakeholder management
- Project management
- Analytical thinking
- Problem-solving
- Report writing
- Leadership skills
Personal Competencies
The ideal candidate should demonstrate:
- Ability to work independently
- Goal-oriented mindset
- Strong attention to detail
- Excellent negotiation skills
- Strong organizational abilities
- Ability to manage multiple projects simultaneously
- High ethical standards and integrity