Job description
Join Parexel International as a Clinical Trial Manager - FSP in Singapore and lead high-impact, global clinical studies from planning through execution. In this pivotal role, you will partner with sponsors, regulatory authorities, ethics committees, and internal cross-functional teams to drive trial success while upholding the highest standards of quality and compliance. This is a dynamic position ideal for a seasoned trial manager who thrives in a global CRO environment and enjoys cultivating strong stakeholder relationships.
As a Clinical Trial Manager, you will own end-to-end study management, including development of comprehensive trial plans, timelines, risk management strategies, and issue resolution. You will ensure timely, submission-ready documentation and regulatory submissions, while maintaining rigorous adherence to ICH-GCP, Parexel SOPs, and sponsor requirements. You will oversee data management, biostatistics, pharmacovigilance, medical writing, and safety activities to deliver clean, high-quality data and reports such as CSR, DSUR, and safety summaries.
In this FSP capacity, you will also manage vendor relationships (CROs and other external resources), monitor performance metrics, and control study budgets and resource allocation. You will mentor and develop junior team members, foster a culture of quality and continuous improvement, and contribute to process optimization across trials. If you are a proactive communicator with strong leadership, excellent organizational abilities, and the drive to deliver on complex programs in a fast-paced environment, this is a compelling opportunity to advance your career with Parexel’s global network.
Responsibility
- Lead end-to-end management of assigned clinical trials (planning, execution, and close-out) ensuring timelines, quality, and budget adherence.
- Serve as primary liaison with sponsors, regulatory authorities, ethics committees, sites, and internal stakeholders; manage communications and escalation pathways.
- Oversee regulatory submissions and preparation of essential trial documentation to support compliance and audit readiness.
- Ensure adherence to ICH-GCP guidelines, Parexel SOPs, and sponsor requirements; maintain accurate trial master file and trial documentation.
- Coordinate cross-functional teams (data management, biostatistics, pharmacovigilance, medical writing, safety) to deliver high-quality deliverables (CRFs, CSR, narratives, safety reports).
- Manage vendor relationships, CROs, and external resources; monitor performance, quality, and adherence to contracts and budgets.
- Lead risk management and issue resolution, implementing mitigation plans and continuous process improvements.
- Mentor and develop junior team members, fostering a collaborative, compliant, and high-performance study environment.
Qualification
- Bachelor’s degree in life sciences or a related field; advanced degree preferred.
- Minimum 5 years of hands-on Clinical Trial Manager or equivalent experience in pharmaceutical/CRO settings; experience with FSP models highly desirable.
- Strong knowledge of ICH-GCP, regulatory submission processes, and ethics committee interactions; experience in Singapore regulatory context is a plus.
- Proven project management and leadership abilities with excellent verbal and written communication skills.
- Experience with CTMS, EDC/EDC-2, data management, biostatistics, and safety/pharmacovigilance workflows.
- Ability to manage multiple trials concurrently in a fast-paced environment; strong vendor management and budget skills.
- Proactive problem-solver with strong stakeholder management and decision-making capabilities.
- Fluency in English; additional languages are a plus.