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About the Role
Syneos Health's Clinical Solutions team members act with a drug development mindset, applying their experience and expertise to understand customer needs and shape solutions. Whether in a Functional Service Provider partnership or a Full-Service environment, you will collaborate with passionate problem solvers to help customers achieve their goals.
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 and investigator payments.
- 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 study scope of work, budget and protocol content, ensuring the clinical project team is aware of contractual obligations.
- Uses clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
- Escalates risks to project manager regarding clinical trial management deliverables (timeline, quality, budget) and out-of-scope activities.
- 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 interact with principal investigators or other site staff.
- Collaborates with other functional leaders to coordinate delivery handoffs and meet study milestones.
- Reviews and provides feedback on other functional plans as they relate to 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, 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, CRF completion, dashboards, Sponsor SOPs, clinical plans and guidelines, data plans and timelines.
- 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 clinical monitoring, central monitoring and site management deliverables within a project and maintains visibility of progress using approved systems and tracking tools.
- Reviews project oversight dashboards and other clinical trial systems to oversee site and patient activities, study team conduct and ensure data reflects timely execution of operational aspects.
- Understands the monitoring strategy required for the study and participates in the development of the study risk assessment plan.
- Is accountable for assigned clinical team members' understanding, compliance, and delivery according to the monitoring strategy, CMP/SMP, and risk plans.
- Reviews content and quality of site and central monitoring documentation to ensure they represent site management activities and convey risks to protocol/GCP compliance, trial conduct, patient safety or data integrity.
- Document requested revisions and approvals in CTMS.
- Ensures deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
- Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities.
- Provides status updates on clinical deliverables and risks to clients, project management and leadership.
- Provides solutions for obstacles in protocol execution and site management.
- Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.
- Supports Inspection Readiness for clinical trial management scope.
- Oversees CRAs and Central Monitors assigned to the study and assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks.
- May develop and support execution of corrective action plans at site and study level.
- Supports and completes activities to achieve data cut and lock deadlines.
- Provides feedback to line managers on staff performance.
- May be assigned to larger, more complex trials.
Requirements
- 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 the achievement of project milestones
- Demonstrated capability of working in an international environment
- Demonstrated expertise in site management and monitoring (clinical or central)
- Preferred experience with risk-based monitoring
- Demonstrates understanding of clinical trial management financial principles and budget management
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills
- Good communication, presentation and interpersonal skills among project team and with sites
- Strong conflict resolution skills
- Demonstrated ability to apply problem solving techniques to resolve complex issues
- Demonstrated ability to apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project
- Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues
Skills
- Clinical monitoring
- Central monitoring
- Site management
- Risk-based monitoring
- Good Clinical Practice (GCP)
- ICH Guidelines
- Computer skills
- Communication skills
- Presentation skills
- Interpersonal skills
- Conflict resolution skills
- Problem-solving techniques
- Risk management
- Critical thinking
Location
- Remote
- Hybrid
- Onsite
Work Type
- Full-time
Experience Level
- CTM I/II
Education Level
- Bachelor's degree
- RN
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
About the Company
- Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success.
- We partner with innovators across the drug development and commercialization continuum.
- 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.
Equal Opportunity
- The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
- Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.