Join a leading global Contract Research Organization (CRO) dedicated to advancing clinical research and delivering breakthrough therapies to address the world’s most pressing health concerns. Our Clinical Research Services team, powered by the renowned PPD® clinical research portfolio, collaborates with top scientific and clinical experts to bring innovative drugs to market. If you’re passionate about clinical research and want to contribute to life-changing healthcare advancements, this opportunity is for you.
Job Responsibilities
As a Senior Clinical Trial Coordinator (Sr. CTC), you will play a pivotal role in managing and supporting clinical trials to ensure their success. Your primary responsibilities include:
- Documentation and Compliance
- Reviewing and reconciling study metrics and findings reports.
- Ensuring Trial Master File (TMF) readiness through file reviews and completeness checks.
- Coordinating and resolving findings related to trial documentation.
- Maintaining study-specific documentation and global support tools.
- Regulatory and Audit Support
- Tracking local regulatory documents and supporting audit readiness.
- Assisting with responses to internal, regulatory, and client audits.
- Keeping (e)TMF systems current and in compliance with guidelines.
- Project Coordination
- Scheduling tasks proactively to align with project needs.
- Managing project-specific training requirements and system access.
- Supporting project leads by analyzing risks and providing solutions.
- Training and Collaboration
- Training new personnel on processes and systems.
- Sharing best practices and collaborating with regional teams.
- Serving as a technical lead for client TMF activities and system support.
Qualifications and Experience
To excel in this role, you should meet the following qualifications:
- Educational Requirements:
- Bachelor’s degree or equivalent experience.
- Experience:
- A minimum of 3 years of relevant experience in clinical trials or a related field.
Key Skills and Competencies
- Proficiency in TMF systems and tools like Activate and eTMF.
- Strong analytical and critical thinking skills.
- Expertise in maintaining compliance with SOPs, regulatory guidelines, and client directives.
- Excellent communication and organizational abilities.
- Technical skills to aggregate and analyze TMF-related data.
- Collaborative mindset with a focus on team training and knowledge sharing.
