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Clinical Trial Manager I – Sponsor Dedicated
Syneos Health. Perform site qualification, site initiation, interim monitoring, site management, and close-out visits on-site or remotely .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Monitoring and Site Management, ensuring compliance with Good Clinical Practice and ICH Guidelines while effectively managing site-level activities and communications. Proficient in data integrity verification, subject recruitment strategies, and maintaining investigational product documentation.
Highest-signal resume keywords
Clinical MonitoringSite ManagementGood Clinical PracticeData Integrity VerificationInvestigational Product Management
ATS Keywords
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Hard Skills
Site QualificationSource Document ReviewClinical Data VerificationElectronic Data Capture ComplianceChart AbstractionData CollectionAction Plan DevelopmentSite Performance EvaluationClinical Monitoring ActivitiesRegulatory Requirements Knowledge
Soft Skills
Excellent CommunicationPresentation SkillsInterpersonal Skills
Tools & Technologies
Clinical Project Data Review SoftwareElectronic Data Capture Systems
Certifications & Qualifications
Bachelor’s DegreeRN in a Related Field
Industry Keywords
ICH GuidelinesGood Clinical PracticeReal World Late Phase Study DesignsSite InitiationSite Close-Out Visits
About the role
Key responsibilities & impact- Perform site qualification, site initiation, interim monitoring, site management, and close-out visits on-site or remotely
- Evaluate site and site staff performance and provide site-specific recommendations
- Escalate serious issues and develop action plans with project team guidance
- Verify informed consent processes, subject/patient confidentiality, safety, and clinical data integrity
- Assess site processes under Clinical Monitoring/Site Management Plans
- Conduct source document review and verify clinical data in case report forms
- Resolve queries remotely and on site within agreed timelines
- Use hardware and software for clinical project data review and capture
- Verify electronic data capture compliance
- Manage investigational product inventory, reconciliation, storage, dispensing, administration, and related documentation
- Review Investigator Site Files and reconcile them with Trial Master Files
- Document monitoring activities through letters, trip reports, communication logs, and project documents
- Support subject/patient recruitment, retention, and awareness strategies
- Track observations, site status, and action items to resolution
- Manage site-level activities and communications to meet project objectives, deliverables, and timelines
- Liaise with project site personnel, CRAs, and Central Monitoring Associates
- Ensure assigned sites and site team members are trained and compliant
- Attend investigator, sponsor, global monitoring, and clinical training meetings
- Support audit readiness, audit preparation, and follow-up actions
- For Real World Late Phase: provide site support throughout the study lifecycle, perform chart abstraction and data collection, and collaborate with sponsor affiliates, medical science liaisons, and local country staff
Requirements
What you’ll need- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Good computer skills and ability to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis
- Ability to perform clinical monitoring and site management activities on-site or remotely
- Knowledge of local requirements for real world late phase study designs, where applicable
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Total Self culture
- Diversity, inclusion, and belonging initiatives