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Clinical Trial Manager – Mexico
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 site management, regulatory compliance, and clinical data integrity, with a strong focus on Good Clinical Practice and effective communication. Proficient in managing investigational products and supporting patient recruitment and retention strategies.
Highest-signal resume keywords
Site ManagementRegulatory ComplianceGood Clinical PracticeClinical Data IntegrityPatient Recruitment
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Site QualificationSite InitiationInterim MonitoringSource Document ReviewElectronic Data CaptureChart AbstractionData CollectionProtocol CompliancePharmacovigilanceInvestigational Product Management
Soft Skills
Excellent CommunicationPresentation SkillsInterpersonal Skills
Tools & Technologies
Clinical Project Data Review SoftwareData Capture Hardware
Certifications & Qualifications
Bachelor’s DegreeRN in a Related Field
Industry Keywords
ICH GuidelinesGCPRegulatory RequirementsReal World Late Phase StudiesTrial Master File
About the role
Key responsibilities & impact- Perform site qualification, site initiation, interim monitoring, site management, and close-out visits on-site or remotely
- Ensure regulatory, ICH-GCP/GPP, and protocol compliance
- Evaluate site and site staff performance and recommend site-specific actions
- Communicate and escalate serious issues and develop action plans
- Verify informed consent processes and protect subject/patient confidentiality
- Assess subject/patient safety, clinical data integrity, protocol deviations/violations, and pharmacovigilance issues
- Conduct source document review and verify clinical data accuracy and completeness
- 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 labeling as applicable
- Review Investigator Site Files and reconcile them with the Trial Master File
- Document activities through confirmation letters, follow-up letters, trip reports, communication logs, and project documents
- Support subject/patient recruitment, retention, and awareness strategies
- Track observations, status, and action items to resolution
- Manage site-level activities and communications to meet project objectives, deliverables, and timelines
- Act as primary liaison with project site personnel or collaborate with CRAs/CMAs
- Ensure assigned sites and project-specific team members are trained and compliant
- Attend investigator and sponsor meetings, global project meetings, and clinical training sessions
- Support audit readiness and audit follow-up actions
- For Real World Late Phase: support sites throughout the study lifecycle, perform chart abstraction/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
- For Real World Late Phase: knowledge of local requirements for real world late phase study designs
- For Real World Late Phase: chart abstraction activities and data collection
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, belonging, and inclusion-focused workplace culture