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

Syneos Health

0-2 years

Not Disclosed

Remote

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

Clinical Trial Manager - Full-Service with experience in USA (Home-Based LATAM)
Location: Brazil (LATAM) - Home-Based
Job ID: 25001160
Updated: January 14, 2025

Description

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success by addressing modern market realities. With a global presence, Syneos Health is passionate about changing lives and brings clinical, medical affairs, and commercial insights to drive therapeutic success. Whether working in a Functional Service Provider partnership or a Full-Service environment, our people collaborate to meet customer goals with agility and innovation.

Why Syneos Health

Employee Growth: Syneos Health is committed to employee development with career progression, technical and therapeutic area training, and a comprehensive rewards program.
Total Self Culture: We support our diverse workforce, enabling everyone to be their authentic self, fostering inclusion and engagement globally.
Building Success Together: We believe in bringing together diverse perspectives, backgrounds, and skills to create a sense of belonging and success.

Job Responsibilities

Oversee site management, clinical monitoring, and central monitoring deliverables to ensure patient safety, protocol/GCP/regulatory compliance, and data integrity.
Manage site activities post-activation through site closeout, including patient recruitment and investigator payments.
Review study scope, budget, and protocol content, ensuring compliance with contractual obligations.
Identify risks related to clinical trial management deliverables, timeline, quality, and budget.
Collaborate with Study Start-Up, Patient Recruitment, and Data Management teams to meet study milestones.
Develop and maintain clinical study tools and templates, ensuring user acceptance testing (UAT) as needed.
Oversee training of the study team regarding protocol, CRF completion, SOPs, clinical plans, and study timelines.
Manage resourcing allocations, site assignments, and study team conduct to ensure quality and delivery.
Use clinical trial systems (e.g., CTMS, EDC) to track site and patient activities and monitor data integrity.
Ensure compliance with ICH GCP and regulatory requirements throughout the trial lifecycle.
Provide escalation and conflict resolution support to site staff and project team members.
Develop and implement risk mitigation strategies and corrective action plans as needed.

Qualifications

Education: Bachelor’s degree or RN in a related field, or equivalent education and experience.
Experience: Proven leadership in clinical trial management, site management, and monitoring.
Knowledge: Familiarity with Good Clinical Practice/ICH Guidelines, clinical trial financial principles, and regulatory requirements.
Skills: Strong communication, presentation, interpersonal, and conflict resolution skills. Proficient in computer usage.
Travel: Up to 20% travel required.

Get to know Syneos Health

Syneos Health has supported over 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products in the past five years, impacting more than 675,000 trial patients across 73,000 sites.

#LI-RR1

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