Clinical Trial Manager II - Sponsor Dedicated - Chile Home Based

Syneos Health, Inc.; Chile; Remote; CLP 12,000,000 - 18,000,000; Full time

Job summary

Syneos Health, Inc. is seeking a Clinical Trial Manager II to be sponsor-dedicated and home-based in Chile.

You will oversee site management, clinical and central monitoring with a focus on patient safety, data integrity and regulatory compliance. You will guide the study team, manage risks via RACT, coordinate trainings, and ensure milestones are met through CTMS/EDC systems while collaborating with cross-functional leaders.

Responsibilities

• Site management oversight, clinical monitoring and central monitoring deliverables focused on patient safety, protocol/GCP/regulatory compliance and data integrity.
• Oversees site interactions from activation through site closeout, including patient recruitment or other related activities.
• Identifies critical data and process risks and mitigations related to RACT (Risk Assessment and Categorization Tool).
• Reviews scope of work, budget and protocol content; ensures the clinical project team (CRAs/Central Monitors) understands contractual obligations and parameters.
• Uses operational data and metrics to identify risks to clinical trial management deliverables.
• Escalates risks to the project manager for timeline, quality and budget concerns and for out-of-scope activities.
• Employs strategic thinking to propose and implement risk mitigations.
• Participates in key meetings such as Kick Off Meeting.
• Acts as escalation point for communications with investigator site staff and may interact with principal investigators or site staff.
• Coordinates training for the study team on protocol specifics, CRF completion, dashboards, SOPs and data plans.
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments and team conduct, identifying risks to delivery or quality.
• Ensures quality of monitoring and site management deliverables and maintains project visibility with approved systems and tracking tools.
• Reviews project oversight dashboards and systems (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, Central Monitoring dashboards) to oversee progress.

Job description

Clinical Trial Manager II - Sponsor Dedicated - Chile Home Based

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job 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. This may include patient recruitment, investigator payments or other related activities.

May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).

Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters.

Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.

Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.

Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.

Participates and presents in key meetings such as Kick Off Meeting.

Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. This may include accompanying CRA team members to sites for observation or conflict resolution.

Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities.

Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. Ensures access and audit trail reviews are conducted as required.

Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.

Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.

Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools.

Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs),Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee