Clinical Trial Manager Ii, Fsp

2+ years

Not Disclosed

Remote - Europe

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: 24006828
Updated: December 16, 2024

Job Description:

Syneos Health is seeking a skilled Clinical Trial Manager II to join our team in Taiwan. This home-based role within our Functional Service Provider (FSP) model will oversee clinical monitoring, site management, and central monitoring activities, ensuring compliance with patient safety, protocols, GCP, and regulatory standards. The role includes managing site interactions, identifying risks, coordinating with cross-functional teams, and ensuring timely trial milestones. If you have a passion for accelerating the delivery of therapies and are experienced in clinical trial management, we encourage you to apply.

Key Responsibilities:

Oversee site management, clinical monitoring, and central monitoring with a focus on patient safety and compliance with GCP, protocol, and regulatory requirements.
Manage site interactions from activation to closeout, including recruitment, investigator payments, and related activities.
Identify risks to trial deliverables and work on risk mitigation strategies to ensure the successful completion of the trial.
Collaborate with Study Start-Up, Data Management, and other functional teams to meet key milestones, such as site activation and database lock.
Ensure the development and maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.
Provide training for the study team on protocol details, CRF completion, and relevant clinical procedures.
Assess quality of monitoring and site management deliverables, ensuring compliance with trial plans.
Participate in risk assessment plans and ensure the clinical team’s understanding of the study’s monitoring strategy.
Provide regular updates on trial progress to clients and internal stakeholders.

Qualifications:

Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
Proven leadership experience in clinical trial management, particularly in international settings.
Expertise in site management, clinical monitoring, and risk-based monitoring.
Strong knowledge of clinical trial financial management and budget oversight.
Excellent communication, conflict resolution, and problem-solving skills.
Familiarity with GCP, ICH Guidelines, and regulatory requirements.
Ability to apply risk management strategies and resolve complex trial issues.
Ability to travel up to 20% of the time.

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Clinical Trial Manager Ii, Fsp

Job Description

Job Description:

Key Responsibilities:

Qualifications:

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