Project Specialist- Parexel x1
Job Details
- Job Title: Project Specialist I
- Company: Parexel
- Locations:
- Bloemfontein
- Lynnwood
- Primary Location: Bloemfontein, South Africa
- Additional Location: Lynnwood (Pretoria), South Africa
- Industry: Clinical Research / Healthcare / Pharmaceuticals
- Department: Global Project Leadership
- Job Level: Project Specialist I
About Parexel
Parexel is a global Clinical Research Organization (CRO) that partners with pharmaceutical, biotechnology, and medical device companies to design and manage clinical trials. The company focuses on accelerating the development of life-changing treatments while maintaining high standards of quality, patient safety, and regulatory compliance.
Job Purpose
The Project Specialist I supports the successful planning, coordination, execution, monitoring, and close-out of clinical research projects. Working closely with Project Leaders (PLs), Functional Leads (FLs), vendors, and clients, the role helps ensure that projects are completed on time, within budget, and in compliance with applicable regulations and company procedures.
The position primarily supports late-phase and Enterprise clinical projects and contributes to project administration, reporting, financial oversight, compliance monitoring, and operational coordination.
Key Responsibilities
1. Project Planning
- Develop and maintain project management plans.
- Assist Project Leaders with project planning activities.
- Update project plans based on study requirements.
- Ensure project timelines remain accurate and current.
- Maintain project planning tools and documentation.
2. Project Administration
- Maintain information within the integrated project management system.
- Update project systems according to Standard Operating Procedures (SOPs).
- Manage project team lists.
- Coordinate project system access.
- Maintain project documentation throughout the project lifecycle.
3. Project Reporting
- Prepare project reports and operational metrics.
- Produce compliance reports.
- Generate reports for internal management.
- Support client reporting requirements.
- Provide data that assists Project Leaders with informed decision-making.
4. Budget and Financial Support
- Conduct initial reviews of project financial information.
- Review vendor invoices.
- Monitor pass-through costs.
- Review time bookings.
- Follow up on corrections where necessary.
- Assist with financial close-out activities.
5. Project Coordination
- Work closely with Project Leaders and Functional Leads.
- Follow up on project action items.
- Monitor project progress.
- Ensure project activities remain aligned with timelines.
- Support cross-functional collaboration.
6. Project Start-up Activities
Responsibilities include:
- Setting up project management plans.
- Customising project systems.
- Supporting vendor selection.
- Creating project-specific training curricula.
- Assisting with Trial Master File (TMF) setup.
- Supporting project resource planning.
- Coordinating insurance documentation.
- Managing Letters of Authorization.
- Supporting system access management.
7. Project Execution
- Maintain project systems throughout study execution.
- Distribute project reports.
- Ensure project documentation remains up to date.
- Monitor project compliance.
- Track operational progress.
8. Project Integration
- Maintain consistency across project management plans.
- Monitor project training compliance.
- Follow up on non-compliance issues.
- Prepare operational review meetings.
- Assist with project oversight reporting.
9. Meeting Management
- Prepare project meetings.
- Attend project meetings.
- Prepare meeting documentation.
- Record and distribute action items.
- Track completion of assigned actions.
10. Vendor Management
- Coordinate with vendors.
- Monitor study supply deliveries.
- Ensure vendor obligations are met.
- Review vendor invoices.
11. Project Close-out
Support project closure by:
- Using close-out checklists.
- Coordinating project completion activities.
- Closing project systems.
- Archiving documentation.
- Preparing financial close-out documentation.
- Ensuring smooth handover to sponsors.
12. Clinical Operations Support
Support the Clinical Operations Leader by:
- Monitoring CTMS compliance.
- Tracking site newsletters.
- Reviewing laboratory reports.
- Reviewing shipment reports.
- Monitoring site staff lists.
- Tracking site closure activities.
- Reviewing vendor reports.
- Monitoring query reports.
- Performing additional delegated operational tasks.
Minimum Educational Requirements
Applicants must have:
- A Bachelor’s degree or equivalent qualification.
Preferred fields include:
- Health Sciences
- Medical Sciences
- Life Sciences
- Biological Sciences
- Pharmacy
- Nursing
- Related scientific disciplines
Experience Requirements
Essential
- Relevant experience in a Project Specialist, Project Planning, Project Support, or similar role.
Advantageous
- Experience in Clinical Research.
- Experience within the pharmaceutical or healthcare industry.
- Experience supporting clinical trials.
- Exposure to project planning and coordination.
Knowledge Requirements
Candidates should have knowledge of:
- Project planning processes.
- Project support functions.
- Microsoft Office applications.
- Clinical research processes (preferred).
- Clinical trial operations (preferred).
- Good Clinical Practice (GCP).
- International Council for Harmonisation (ICH) guidelines.
Technical Skills
Applicants should possess:
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Outlook
- Project management systems
- Data management skills
- Reporting skills
- Documentation management
- Financial tracking
- Administrative skills
Soft Skills
The successful candidate should demonstrate:
- Excellent verbal communication.
- Strong written communication.
- Intermediate to advanced English proficiency.
- Strong interpersonal skills.
- Relationship-building ability.
- Attention to detail.
- Quality-focused work ethic.
- Client-focused mindset.
- Flexibility.
- Adaptability.
- Time management.
- Organisation.
- Multitasking ability.
- Prioritisation skills.
- Teamwork.
- Problem-solving ability.
- Initiative.
- Accountability.
Personal Attributes
Parexel is seeking candidates who are:
- Adaptable
- Strong communicators
- Collaborative
- Proactive
- Effective leaders
- Analytical thinkers
- Detail-oriented
- Customer-focused
- Eager to learn
- Able to work independently and within cross-functional teams
Working Environment
The Project Specialist I works within Parexel’s Global Project Leadership team, collaborating with:
- Project Leaders
- Functional Leads
- Clinical Operations teams
- Sponsors
- Vendors
- Clients
- Global cross-functional project teams
The role operates in a matrix environment and may involve supporting international clinical research projects.
Career Development Opportunities
This role offers opportunities to develop expertise in:
- Clinical project management
- Clinical operations
- Project leadership
- Clinical trial coordination
- Financial project management
- Vendor management
- Regulatory compliance
- Global clinical research
With experience, progression may be possible into roles such as:
- Project Specialist II
- Senior Project Specialist
- Clinical Project Manager
- Project Leader
- Clinical Operations Leader