Clinical Trial Manager Ii

0-2 years

Not Disclosed

Remote Korea

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

Here’s a concise summary for the role of Clinical Trial Manager II based in Korea Republic of-Asia Pacific:

Clinical Trial Manager II

Location: Korea Republic of-Asia Pacific - KOR-Home-Based
Job ID: 25001204

About Syneos Health

Syneos Health® is a global biopharmaceutical solutions organization focused on accelerating customer success. With 29,000 employees across 110 countries, Syneos Health is committed to delivering clinical, medical affairs, and commercial insights that drive outcomes and improve lives.

Why Join Syneos Health?

Career Growth: Focus on development through training, mentorship, and recognition programs.
Total Self Culture: Encourages authenticity, diversity, and belonging for a better workplace.

Key Responsibilities

Oversee site management, clinical monitoring, and central monitoring with a focus on safety, compliance, and data integrity.
Manage site interactions from activation to closeout, including patient recruitment and payments.
Identify and mitigate risks in trial management using data, metrics, and strategic thinking.
Serve as a primary escalation point for investigator site communications, including conflict resolution.
Collaborate across functions to achieve milestones such as site activation and database lock timelines.
Develop and maintain study tools, including Clinical Monitoring Plans and dashboards.
Ensure quality in site and central monitoring documentation and escalate issues where necessary.
Support inspection readiness and ensure compliance with GCP, ICH Guidelines, and country regulations.
Lead and align teams to meet project milestones, providing feedback on performance and areas for growth.

Qualifications

Education: Bachelor’s degree or RN in a related field, or equivalent experience.
Skills:
- Proven leadership in achieving project milestones.
- Expertise in site management, monitoring, and risk-based monitoring approaches.
- Financial and budget management knowledge in clinical trial settings.
- Strong conflict resolution and problem-solving skills.
- Proficient in regulatory requirements and GCP/ICH Guidelines.
Travel: Moderate (approximately 20%).

Additional Information

Syneos Health supports diversity, inclusion, and compliance with regulatory and accessibility guidelines.
Tasks and responsibilities may evolve based on organizational needs.

For more information about Syneos Health and their impact, visit their website.

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Clinical Trial Manager Ii

Job Description

Clinical Trial Manager II

About Syneos Health

Why Join Syneos Health?

Key Responsibilities

Qualifications

Additional Information

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