Clinical Trial Manager Full-Service With Experience In Usa - Home Based Latam

0-2 years

Not Disclosed

Remote - South America (Latin Americal)

10 Jan. 16, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Trial Manager Full-Service with experience in USA - Home Based LATAM (Argentina)

Job Location: Argentina-Latin America - ARG-Home-Based
Job ID: 25001160
Date Updated: January 14, 2025

Company Overview: Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We focus on clinical, medical affairs, and commercial insights to drive outcomes in a dynamic market. Our Clinical Development model centers on the patient and customer. We strive to simplify and innovate our approach, creating a workplace where employees thrive.

Why Syneos Health: We prioritize career development through training, progression, peer recognition, and rewards. Our culture celebrates individuality and diversity, fostering an environment where everyone feels valued and respected.

Key Responsibilities:

Oversee site management, clinical monitoring, and central monitoring deliverables, ensuring compliance with protocols, GCP, regulatory standards, and data integrity.
Manage site activities post-activation through to closeout, including patient recruitment and investigator payments.
Identify risks related to protocol execution and provide mitigation plans.
Ensure team adherence to the scope of work, budget, and protocol specifications.
Collaborate with project managers to identify risks to timelines, quality, and budget.
Present in key meetings and support CRA team members in site management or conflict resolution.
Coordinate with functional leaders in Study Start-Up, Patient Recruitment, and Data Management to meet study milestones.
Develop and maintain clinical study tools, templates, and monitoring plans.
Manage training for the study team on protocols, data collection, and clinical guidelines.
Review and assess study-related documents and systems (e.g., CTMS, EDC, IVRS) to ensure proper execution.
Interact with clients and other departments, providing status updates and solutions for potential obstacles.
Support inspection readiness and quality assurance activities.

Qualifications:

Bachelor’s degree or RN in a related field, or equivalent experience.
Proven experience leading teams to achieve project milestones in an international environment.
Expertise in site management and clinical monitoring, including risk-based monitoring.
Strong understanding of clinical trial management financial principles and budget management.
Knowledge of Good Clinical Practice (GCP) and ICH Guidelines.
Excellent communication, presentation, and interpersonal skills.
Conflict resolution and critical thinking skills.
Ability to apply problem-solving techniques and risk management strategies.
Moderate travel required (approximately 20%).

About Syneos Health:
Syneos Health has worked with 94% of all Novel FDA-approved drugs and 95% of EMA-authorized products. We collaborate with over 200 studies across 73,000 sites and 675,000+ trial patients.

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Clinical Trial Manager Full-Service With Experience In Usa - Home Based Latam

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