What does a Project Leader do at Parexel?

Explore the responsibilities, collaboration, and growth opportunities of a Project Leader in the clinical research industry

Q: What are the job responsibilities of a Project Leader?

A: Project Leader responsibilities throughout the clinical trial lifecycle:

• Project Initiation: Launch the project by assessing feasibility, conducting kick-off meetings, and establishing goals and timelines.

• Compliance Management: Ensure adherence to regulations, maintain system compliance, and align with third-party suppliers.

• Quality Oversight: Monitor quality factors, implement risk management strategies, and collaborate with Quality Assurance teams.

• Progress Monitoring: Oversee budget and resources, conduct regular reviews, and proactively address potential issues.

• Change Management: Develop risk mitigation strategies, plan for various scenarios, and manage scope changes effectively.

• Stakeholder Communication: Coordinate teams, engage clients, and facilitate effective communication across all project stakeholders.

• Project Closure: Finalize reporting, close systems, reconcile budgets, and ensure all contractual obligations are met.

Q: Which roles do I collaborate with as a PL?

A: Project Leaders collaborate with a wide range of internal and external stakeholders, including:

• Clients (sponsors from pharmaceutical and biotech companies)
• Clinical Operations Leaders/Clinical Trial Managers
• Clinical Research Associates (CRAs)
• Functional Leads (e.g., Data Management, Biostatistics, Medical Writing)
• Regulatory Affairs Specialists
• Client Contract Managers
• Project Financial Business Partners
  
  

Q: What technologies or tools do PLs use in their daily work?

A: To deliver excellent Clinical Trial Management, Project Leaders use a:

• Project Management and Planning Tool

• Electronic Document Management System (eDMS) and Electronic Trial Master File (eTMF) System

• Clinical Trial Management System (CTMS)

• Project Review and Oversight Platform

• Clinical Trial Monitoring and Risk Management System

• Interactive Response Technology (IRT) System for Subject and Product Management

• Pharmacovigilance and Safety Information System

• Quality Management System (QMS)

Q: What training and development opportunities are available for Project Leaders at Parexel?

A: The following training is offered at Parexel:

• Corporate training curriculum
• Functional training curriculum
• Partnership training
• Project-specific training
• On-the-job training: All types of visits/tasks
• On-the-job mentoring by experienced colleagues
• Continued education & professional development: Workshops, Functional Role Forums, Professional Skills Training, Therapeutic Area Training, Functional Role Toolkits

Q: Will I have to travel as a Project Leader?

A: Some travel may be required as a Project Leader, but the extent can vary depending on the specific project and role. Travel might include:

• Attend investigator meetings or conferences.
• Face-to-face meetings with sponsors or team members.

However, with the increasing use of virtual communication tools in pharmaceutical research, travel requirements have generally decreased in recent years.

Q: Are there remote job opportunities as a Project Leader?

A: Yes, Parexel provides flexible work arrangements for Project Leaders, including remote and hybrid options.  While some on-site presence may be required for above mentioned key events, the majority of PL work can be successfully managed remotely. Parexel strives to support flexibility while ensuring project success and client satisfaction.

Q: Are there opportunities to work across multiple therapeutic areas or types of clinical trials?

A: Yes, there are opportunities for Project Leaders (COLs) to work on multiple therapeutic areas or types of clinical trials. It's important to note that while these opportunities likely exist, the extent and nature can vary based on the current project portfolio. PLs interested in specific areas should discuss their aspirations with their line managers to align their career development with organizational needs and opportunities.

• As one of the largest global CROs, Parexel conducts trials across a wide range of therapeutic areas, clinical trial phases (Phase I, II, III, or IV), and geographies.
• Parexel also works on cutting-edge areas like cell and gene therapy, precision oncology, and patient-guided drug development.
• With the increasing use of technology in clinical trials, PLs operate in decentralized or hybrid trials, leveraging digital health technologies.

Q: What career progression is typical for a Project Leader?

A: A typical career progression for a Project Leader may include:

• Starting as an Associate Project Leader.
• Advancing to a Project Leader and Senior Project Leader.

• Branching to either Project Director or Management Roles.

How does a Project Leader role differ from the common industry title Project Manager?

A: The Project Leader (PL) role at Parexel is essentially the same as the Project Manager (PM) role commonly used in the industry. While the titles differ, the core responsibilities and functions are identical. Both roles involve overseeing clinical trials, managing teams, and ensuring project success.

At Parexel, we use "Project Leader" to emphasize the leadership aspect, reflecting our commitment to empowering professionals to drive projects forward. However, the core responsibilities, required skills, and career progression are very similar to those of a PM.

When comparing opportunities or discussing roles across the industry, you can generally consider Project Leader and Project Manager titles as interchangeable in terms of duties and career development potential.