Clinical Trial Manager Ii, Fsp

2+ years

Not Disclosed

Remote, USA

10 Dec. 18, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 II, FSP
Location: Taiwan (Greater China) – Home-Based
Job ID: 24006830
Updated: December 16, 2024

Job Description:

Syneos Health is seeking an experienced Clinical Trial Manager II to join our team in Taiwan. As a home-based role within our Functional Service Provider (FSP) model, you will oversee site management, clinical monitoring, and central monitoring deliverables, ensuring patient safety, protocol compliance, and data integrity throughout the trial lifecycle. You will manage all site interactions from activation through closeout, mitigate risks, and coordinate with cross-functional teams to ensure milestones are met. The position requires a strong background in clinical trial management, leadership skills, and the ability to work in an international environment.

Key Responsibilities:

Oversee site management, clinical monitoring, and central monitoring, ensuring compliance with patient safety, protocol, GCP, and regulatory standards.
Manage all aspects of the trial from site activation to closeout, including patient recruitment and investigator payments.
Identify risks to study deliverables and propose mitigations to ensure on-time and within-budget trial completion.
Provide oversight on clinical trial budgets, scope of work, and protocol, and ensure the project team (CRAs, CeMs) adheres to contractual obligations.
Collaborate with Study Start-Up, Data Management, Patient Recruitment, and other teams to meet site activation, enrollment, and database lock targets.
Develop and maintain clinical study tools and templates, including monitoring and communication plans.
Conduct training for the study team on protocol specifics, CRF completion, and clinical plans.
Evaluate the quality of clinical deliverables and provide ongoing guidance to CRAs and Central Monitors.
Provide feedback on staff performance, resolve conflicts, and support study milestones.

Qualifications:

Bachelor's degree or RN in a related field, or equivalent combination of education and experience.
Proven leadership in clinical trial management and the ability to align teams with project milestones.
Extensive experience in site management, monitoring, and risk-based monitoring.
Understanding of clinical trial management financial principles and budget management.
Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
Strong problem-solving, conflict resolution, and communication skills.
Moderate travel required (up to 20%).

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Clinical Trial Manager Ii, Fsp

Job Description

Job Description:

Key Responsibilities:

Qualifications:

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