Senior Clinical Trial Manager - FSP (Tagalog proficient)

📋 Description

• • Syneos Health is seeking a Senior Clinical Trial Manager (FSP) to oversee clinical trial operations, ensuring patient safety, protocol adherence, and data integrity across multiple sites. This role is crucial in accelerating the development of biopharmaceutical solutions, translating scientific insights into tangible outcomes that address modern market realities and shorten the distance from lab to life.
• • As a Senior Clinical Trial Manager, you will be responsible for comprehensive site management oversight, including clinical monitoring and central monitoring deliverables. You will manage site interactions from post-activation through site closeout, potentially overseeing activities such as patient recruitment and investigator payments. A key aspect of this role involves identifying critical data and processes, assessing protocol execution risks, and implementing effective risk mitigation strategies using tools like the Risk Assessment and Categorization Tool (RACT).
• • You will meticulously review study scope of work, budget, and protocol content, ensuring the clinical project team, including CRAs and Central Monitors, fully understands contractual obligations and parameters. Leveraging your prior clinical experience, operational data, metrics, and reports, you will proactively identify risks to clinical trial management deliverables, such as timelines, quality, and budget. Any risks or out-of-scope activities will be promptly escalated to the project manager.
• • Strategic thinking and advanced problem-solving skills are essential for proposing and implementing effective risk mitigation plans. You will actively participate in and present at key meetings, including Kick-Off Meetings, and serve as a primary escalation point for communications with investigator site staff. This may involve direct interaction with principal investigators and other site staff, and potentially accompanying CRA team members to sites for observation or conflict resolution.
• • Collaboration is key in this role. You will work closely with other functional leaders, including Study Start Up, Patient Recruitment, and Data Management teams, to coordinate delivery handoffs and ensure critical study milestones, such as site activation targets, enrollment goals, and database lock timelines, are met. You will also review and provide feedback on other functional plans, such as Data Management Plans and Communication Plans, as they pertain to clinical trial management activities.
• • You will be responsible for the development and ongoing maintenance of essential clinical study tools and templates, including the Clinical Monitoring Plan. Ensuring that systems like the Clinical Trial Management System (CTMS), dashboards, and other relevant platforms are correctly set up and available for the clinical team is vital. This includes overseeing user acceptance testing (UAT) and ensuring access and audit trail reviews are conducted as required.
• • The role involves coordinating initial and ongoing training for the study team on protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans, guidelines, data plans, and study timelines. You will oversee resourcing allocations for CRAs and Central Monitors, manage site assignments, and monitor study team members' conduct, identifying any risks to delivery or quality.
• • Ensuring the quality of clinical monitoring, central monitoring, and site management deliverables within a project is paramount. You will maintain visibility of progress using approved systems and tracking tools. This includes reviewing project oversight dashboards and other clinical trial systems (e.g., CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, Central Monitoring dashboards) to monitor site and patient activities, study team conduct, and ensure data reflects timely execution of all operational aspects according to the plan.
• • You will understand the study's monitoring strategy and, where necessary, participate in developing the study risk assessment plan. You are accountable for ensuring your assigned clinical team members understand, comply with, and deliver according to the stated monitoring strategy, Clinical Monitoring Plan (CMP)/Site Management Plan (SMP), and risk plans.
• • A critical responsibility is reviewing the content and quality of site and central monitoring documentation, including site monitoring calls, site visit reports, site letters, central monitoring reports, and pertinent correspondence. This ensures these documents accurately reflect site management activities and conduct, and appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety, or data integrity. You will document requested revisions and approvals in CTMS and ensure deliverables meet company and/or sponsor specifications and deadlines.
• • You will interact with clients and other functional departments regarding clinical monitoring, central monitoring, and site management activities. Providing status updates on clinical deliverables and risks to clients, project management, and leadership is essential, as is offering solutions for obstacles in protocol execution and site management.
• • You will demonstrate a thorough understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP, and country regulations. This includes data management, study start-up, patient recruitment, medical monitoring, pharmacovigilance, and Quality Assurance (QA). You will also support Inspection Readiness for the clinical trial management scope.
• • Overseeing CRAs and Central Monitors assigned to the study, you will routinely assess study-specific process and training compliance, CMP compliance, and identify emerging risks. You may develop and support the execution of corrective action plans at the site and study level, and support activities to achieve data cut and lock deadlines. You will provide feedback to line managers on staff performance, including strengths and areas for development. This role may involve managing larger, more complex trials.
• • About the Team/Company: Syneos Health is a leading integrated biopharmaceutical solutions organization with a global presence across 110 countries, employing over 29,000 people. They are passionate about developing their people through career progression, training, and recognition, fostering a 'Total Self' culture where authenticity and belonging are paramount. They have a strong track record, having worked with 94% of Novel FDA Approved Drugs and 95% of EMA Authorized Products in the past five years.
• • What you can learn/achieve: This role offers the opportunity to lead complex clinical trials, develop strategic risk management skills, enhance cross-functional collaboration, and gain deep insights into the biopharmaceutical development process. You will contribute to bringing life-changing therapies to patients faster and grow your career within a supportive and dynamic global organization.
• • Competitive salary and comprehensive benefits package.
• • Opportunities for professional development, training, and career advancement.
• • A collaborative and inclusive work environment that values diversity and authenticity.