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Clinical Trial Manager – CTM, Argentina, Brazil, Chile, Colombia, Mexico
Syneos HealthClinical Trial Manager overseeing site management and monitoring activities with a focus on regulatory compliance in Latin America. Collaborating with clinical teams and maintaining quality data for successful trials.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits
- Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient
- Demonstrates diligence in protecting the confidentiality of each subject/patient
- Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations
- Assesses site processes
- Conducts Source Document Review of appropriate site source documents and medical records
- Applies query resolution techniques remotely and on site
- Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture
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
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis
Benefits
Comp & perks- 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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
site qualificationsite initiationinterim monitoringsite managementclose-out visitsquery resolutionSource Document Reviewclinical data integrityinformed consentprotocol deviation
Soft Skills
communication skillspresentation skillsinterpersonal skillsjudgmentdiligenceevaluation skillsrecommendation skillsconfidentiality protectionsafety assessmentadaptability to new technologies
Certifications
Bachelor’s degreeRN license