Clinical Trial Manager with experience working with United States as a CTM - Argentina, Brazil, Chile, Colombia or Mexico Home Based

Syneos Health, Inc.

Job Overview

Location

5 Locations

Job Type

Full-time

Full Job Description

📋 Description

• Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) to ensure compliance with ICH-GCP, Good Pharmacoepidemiological Practices (GPP), and protocol requirements.
• Verify that informed consent processes are properly documented for each subject/patient and safeguard patient confidentiality throughout the clinical trial lifecycle.
• Conduct source document reviews and verify accuracy and completeness of clinical data entered into case report forms (CRFs), applying query resolution techniques both remotely and on-site.
• Monitor and ensure compliance with electronic data capture (EDC) requirements at investigator sites, utilizing available software and hardware systems to support data review and capture.
• Manage investigational product (IP) inventory, reconciliation, storage, and security; confirm IP is dispensed and administered per protocol, and verify proper relabeling, import, and return procedures in alignment with GCP and local regulations.
• Routinely audit and reconcile the Investigator Site File (ISF) for accuracy, timeliness, and completeness, ensuring alignment with the Trial Master File (TMF) and adherence to local archiving regulations.
• Document all monitoring activities through confirmation letters, trip reports, follow-up correspondence, and communication logs as required by company SOPs and Clinical Monitoring/Site Management Plans.
• Support subject recruitment and retention strategies, entering observations and action items into tracking systems to ensure timely resolution and project progress.
• Manage site-level activities within assigned project scope, budgets, and timelines, adapting quickly to changing priorities under the guidance of the Lead CRA to meet project deliverables.
• Serve as primary liaison between sponsor and site personnel, ensuring all site team members are trained and compliant with regulatory and procedural requirements.
• Prepare for and participate in Investigator Meetings, sponsor face-to-face meetings, and global clinical monitoring/project staff meetings, including interactions with Sponsor representatives.
• Provide guidance to sites to achieve audit readiness and support preparation for regulatory audits, including follow-up on required corrective actions.
• For Real World Late Phase studies, perform chart abstraction and data collection, collaborate with Sponsor affiliates, medical science liaisons, and local country staff, and apply knowledge of regional requirements for real-world study designs.
• Maintain current knowledge of ICH/GCP guidelines, applicable regulatory standards, and company standard operating procedures (SOPs) to ensure consistent compliance across all assigned sites.
• Travel up to 75% regularly to conduct on-site monitoring activities across Argentina, Brazil, Chile, Colombia, or Mexico.
• Ensure compliance with site-specific access requirements in the United States, including providing medical and personal information as requested by U.S. facilities to maintain access privileges.

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience
• Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and applicable regulatory requirements
• Ability to manage required travel of up to 75% on a regular basis
• Excellent communication, presentation, and interpersonal skills
• Demonstrated computer skills and ability to embrace new technologies
• US ONLY: Willingness to provide medical and personal information to gain access to U.S. study sites as required by facility policies

🏖️ Benefits

• Career development and progression opportunities
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Inclusive culture supporting authentic self-expression
• Purpose-driven work focused on accelerating patient progress

Skills & Technologies

GCP

Remote

Degree Required

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Syneos Health, Inc.

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About Syneos Health, Inc.

Syneos Health is a global biopharmaceutical services organization providing clinical and commercial solutions. It integrates clinical development, outsourced commercialization, consulting, and communications services to accelerate the delivery of therapies to market. The company supports pharmaceutical, biotechnology, and medical device clients across all phases of product development and commercialization, operating in North America, Europe, and Asia-Pacific.

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