Clinical Trial Manager, FSP, Indonesia

Overview

Clinical Trial Manager, FSP, Indonesia – Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. WORK HERE MATTERS EVERYWHERE.

Responsibilities

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol / GCP / regulatory compliance and data integrity.
• Oversees site interactions post activation through site closeout, including patient recruitment, investigator payments or other related activities.
• Identify critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
• Review study scope of work, budget and protocol content and ensure the clinical project team is aware of contractual obligations and parameters.
• Use prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
• Escalate risks to the project manager and any activities / requests out of contracted scope.
• Apply strategic thinking and problem-solving to propose and implement risk mitigations.
• Participate and present in key meetings such as Kick Off Meeting.
• Serve as an escalation point for communications with investigator site staff and may interact with principal investigators or site staff as needed.
• Collaborate with functional leaders to coordinate delivery handoffs and meet milestones (site activation, enrollment, database lock). Review and provide feedback on related plans (e.g., Data Management Plan, Communication Plan).
• Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan. Ensure CTMS, dashboards and systems are set up and available; oversee user acceptance testing and audit trails as required.
• Coordinate training to the study team regarding protocol specifics, CRF completion, dashboards, sponsor SOPs, data plans and timelines.
• Oversee resourcing allocations for CRAs and Central Monitors, site assignments and team conduct, identifying risks to delivery or quality.
• Ensure quality of monitoring and site management deliverables, using approved systems / tools to track progress.
• Review project oversight dashboards and trial systems (CTMS, EDC, eDiary, ePROs, TMF, IVRS / IWRS, Central Monitoring dashboards) to ensure timely data and activity updates.
• Understand monitoring strategy and contribute to study risk assessment plans; ensure team compliance with CMP / SMP and risk plans.
• Review site and central monitoring documentation for accuracy and completeness; communicate risks to protocol / GCP compliance and data integrity.
• Interact with client and other functions to provide status updates and resolve obstacles in protocol execution and site management.
• Demonstrate understanding of other functions' roles and support inspection readiness for clinical trial management scope.
• Oversee CRAs and Central Monitors; assess training compliance and risks; support corrective actions as needed and help achieve data cut / lock deadlines.
• Provide feedback to line managers on staff performance and may contribute to larger, more complex trials.

Qualifications

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and responsibilities. The Company will determine what constitutes equivalent qualifications and may consider equivalent experience, skills, and education. The language herein is intended to comply with obligations in each country of operation, including the EU Equality Directive. The Company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations when appropriate.

Summary

Roles within the Clinical Trial Management job family are responsible for all aspects of development, coordination, and implementation of Phase 1 clinical research studies. They collaborate with investigators and client teams, plan logistics and resource usage, track study progress, and ensure compliance with regulations. Supervises and guides designated staff to achieve study milestones and deliverables.

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