What does a Clinical Operations Leader / Clinical Trial Manager do?

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

Q: What are the job responsibilities of a Clinical Operations Leader?

A: Clinical Operations Leaders working at a CRO are responsible for:

• Serving as the primary clinical contact.

• Overseeing and directing clinical project activities.

• Ensuring timeliness and quality of clinical deliverables.

• Coordinating and delivering clinical project-specific training.

• Developing clinical project tools.

• Contributing to patient recruitment plan development and implementation.

• Ensuring accuracy and completion of tracking documents.

• Working closely with the Project Leader to ensure timelines are met.

• Ensuring compliance with FDA/EMA/ regulations, ICH/GCP guidelines, and SOPs.

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

A: As a Clinical Operations Leader, you will collaborate with various roles, including:

• Project Leaders
• Clinical Research Associates (CRAs)
• Functional Leads (e.g., Data Management, Biostatistics, Medical Writing)
• Site Staff and Investigators
• Sponsors and Client Representatives
• Regulatory Affairs Specialists
• Quality Assurance Teams
• Line Managers
• Other Clinical Operations Leaders

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

A: To deliver excellent Clinical Trial Management, Clinical Operations Leaders / Clinical Trial Managers 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 Clinical Operations Leaders at Parexel?

A: Parexel offers a comprehensive training program combining instructor-led sessions and self-paced learning modules, including:

• 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 Clinical Operations Leader?

A: Some travel may be required as a Clinical Operations 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 Clinical Operations Leader?

A: Yes, Parexel offers remote and hybrid work options for Clinical Operations Leaders. Many COLs work remotely, leveraging digital tools and platforms to collaborate effectively with their global metrix teams. However, some on-site presence may be required for certain meetings or events. The specific arrangement can depend on project needs, client preferences, and individual circumstances.

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

A: Yes, Parexel offers Clinical Operations Leaders diverse opportunities across multiple therapeutic areas and trial types. Our Clinical Operations are organized regionally rather than by therapeutic focus, enabling this versatility. It's important to note that while these opportunities likely exist, the extent and nature can vary based on the current project portfolio. COLs 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, COLs operate in decentralized or hybrid trials, leveraging digital health technologies.

Q: What career progression is typical for a Clinical Operations Leader?

A: A typical career progression for a Clinical Operations Leader may include:

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

• Branching to either Principal Clinical Operations Leader or Management Roles.

• Moving into Project Leadership, Quality, or Data Operations.

How does a Clinical Operations Leader role differ from the common industry title Clinical Trial Manager?

A: The Clinical Operations Leader (COL) role at Parexel is essentially the same as the Clinical Trial Manager (CTM) role commonly used in the industry. While the titles differ, the core responsibilities and functions are identical. Both roles involve overseeing clinical operations, ensuring high-quality deliverables, and fostering team collaboration.

At Parexel, we use "Clinical Operations Leader" to emphasize the leadership aspect. This title reflects our commitment to empowering our professionals to take ownership of their projects and lead with excellence. However, the day-to-day tasks, required skills, and career progression closely mirror those of a CTM. This is why our job postings often use "Clinical Operations Leader/Clinical Trial Manager," recognizing both our internal title and the industry-standard term.