Experienced Clinical Trial Manager - Full-Service
Syneos Health/ inVentiv Health Commercial LLC, Florida, NY, United States
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, including patient recruitment, investigator payments or other related activities. May identify critical data/process risks and implement mitigations via the Risk Assessment and Categorization Tool (RACT).
Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of contractual obligations and parameters. Uses operational data, metrics and reports to identify risks to clinical trial management deliverables and escalates any out‑of‑scope activities to the project manager.
Employs strategic thinking to propose and implement risk mitigations. Participates and presents in key meetings such as Kick Off Meeting.
Serves as escalation point for communications with investigator site staff and may interact on the phone or in person with principal investigators or other site staff. May accompany 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 (site activation targets, enrollment targets, database lock timelines). Reviews and provides feedback on related functional plans.
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, and oversees user acceptance testing (UAT) as needed.
Coordinates training for the study team regarding protocol specifics, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines.
Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team conduct. Identifies risks to delivery or quality and ensures quality of monitoring deliverables through approved systems and tracking tools.
Reviews project oversight dashboards and other clinical trial systems (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, Central Monitoring dashboards) to oversee site and patient activities and ensure data updates reflect timely execution of operational aspects.
Understands the monitoring strategy required for the study; participates in development of the study risk assessment plan and is accountable for their assigned team’s compliance and delivery according to the monitoring strategy, CMP/SMP and risk plans.
Reviews site and central monitoring documentation to ensure accurate representation of site management activities and to document required revisions and approvals in CTMS.
Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and provides status updates and risk mitigation solutions.
Demonstrates understanding of other functions’ roles in compliance and delivery, supporting inspection readiness for the scope of clinical trial management.
Oversees CRAs and Central Monitors, assesses training compliance and identifies emerging risks. Develops and supports corrective action plans and supports activities to achieve data cut and lock deadlines.
Provides feedback to line managers on staff performance, including strengths and areas for development.
May be assigned to larger, more complex trials or coordinate clinical activities for a portfolio of projects.
May coach and mentor CTMs regarding functional delivery, risk evaluation and action implementation.
Qualifications
Bachelor's degree or RN in a related field, or equivalent combination of education, training and experience.
Demonstrated ability to lead and align teams in achieving project milestones.
Experience working in an international environment.
Expertise in site management and monitoring (clinical or central).
Preferred experience with risk‑based monitoring.
Understanding of clinical trial management financial principles and budget management.
Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and applicable regulatory requirements.
Proficient computer skills.
Strong conflict resolution skills.
Problem‑solving skills with application of risk‑management approaches to mitigate threats to clinical research conduct.
Critical‑thinking ability to diagnose issues and determine appropriate solutions.
Travel may be required, approximately 20%.
Benefits
The benefits for this position may include a company car or car allowance, health benefits (medical, dental and vision), company match 401(k), eligibility to participate in the Employee Stock Purchase Plan, eligibility to earn commissions/bonuses based on individual and company performance, and flexible paid time off (PTO) and sick time.
Salary Range
$114,000.00 – $210,900.00
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 job responsibilities. Equivalent experience, skills and/or education will also be considered.
The Company is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations when appropriate to assist employees or applicants in performing the essential functions of the job.
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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. May identify critical data/process risks and implement mitigations via the Risk Assessment and Categorization Tool (RACT).
Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of contractual obligations and parameters. Uses operational data, metrics and reports to identify risks to clinical trial management deliverables and escalates any out‑of‑scope activities to the project manager.
Employs strategic thinking to propose and implement risk mitigations. Participates and presents in key meetings such as Kick Off Meeting.
Serves as escalation point for communications with investigator site staff and may interact on the phone or in person with principal investigators or other site staff. May accompany 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 (site activation targets, enrollment targets, database lock timelines). Reviews and provides feedback on related functional plans.
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, and oversees user acceptance testing (UAT) as needed.
Coordinates training for the study team regarding protocol specifics, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines.
Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team conduct. Identifies risks to delivery or quality and ensures quality of monitoring deliverables through approved systems and tracking tools.
Reviews project oversight dashboards and other clinical trial systems (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, Central Monitoring dashboards) to oversee site and patient activities and ensure data updates reflect timely execution of operational aspects.
Understands the monitoring strategy required for the study; participates in development of the study risk assessment plan and is accountable for their assigned team’s compliance and delivery according to the monitoring strategy, CMP/SMP and risk plans.
Reviews site and central monitoring documentation to ensure accurate representation of site management activities and to document required revisions and approvals in CTMS.
Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and provides status updates and risk mitigation solutions.
Demonstrates understanding of other functions’ roles in compliance and delivery, supporting inspection readiness for the scope of clinical trial management.
Oversees CRAs and Central Monitors, assesses training compliance and identifies emerging risks. Develops and supports corrective action plans and supports activities to achieve data cut and lock deadlines.
Provides feedback to line managers on staff performance, including strengths and areas for development.
May be assigned to larger, more complex trials or coordinate clinical activities for a portfolio of projects.
May coach and mentor CTMs regarding functional delivery, risk evaluation and action implementation.
Qualifications
Bachelor's degree or RN in a related field, or equivalent combination of education, training and experience.
Demonstrated ability to lead and align teams in achieving project milestones.
Experience working in an international environment.
Expertise in site management and monitoring (clinical or central).
Preferred experience with risk‑based monitoring.
Understanding of clinical trial management financial principles and budget management.
Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and applicable regulatory requirements.
Proficient computer skills.
Strong conflict resolution skills.
Problem‑solving skills with application of risk‑management approaches to mitigate threats to clinical research conduct.
Critical‑thinking ability to diagnose issues and determine appropriate solutions.
Travel may be required, approximately 20%.
Benefits
The benefits for this position may include a company car or car allowance, health benefits (medical, dental and vision), company match 401(k), eligibility to participate in the Employee Stock Purchase Plan, eligibility to earn commissions/bonuses based on individual and company performance, and flexible paid time off (PTO) and sick time.
Salary Range
$114,000.00 – $210,900.00
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 job responsibilities. Equivalent experience, skills and/or education will also be considered.
The Company is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations when appropriate to assist employees or applicants in performing the essential functions of the job.
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