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Senior Clinical Trial Manager / Clinical Trial Manager Ii (Hybrid Or Home-Based)

Syneos Health
Syneos Health
5-10 years
preferred by company
10 Feb. 5, 2026
Job Description
Job Type: Full Time Hybrid 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

Senior Clinical Trial Manager / Clinical Trial Manager II (Hybrid or Home-Based)

Updated: February 3, 2026
Location: Belgrade, Serbia (Hybrid or Home-Based)
Job ID: 25105347-OTHLOC-3256-2DH
Employment Type: Full-Time | Clinical Operations


About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating the delivery of innovative therapies worldwide. By combining clinical development, medical affairs, and commercial expertise, Syneos Health partners with sponsors to bring treatments from lab to life efficiently and responsibly. With more than 29,000 professionals across 110+ countries, Syneos Health is recognized for operational excellence, regulatory compliance, and patient-centric clinical research.


Position Overview

The Senior Clinical Trial Manager / Clinical Trial Manager II is responsible for the end-to-end operational oversight of Phase I–IV clinical trials. This role ensures high-quality study execution with a strong focus on patient safety, regulatory compliance, data integrity, and delivery against timelines and budgets. The position operates in a hybrid or home-based model and collaborates closely with cross-functional and global stakeholders.


Key Responsibilities

Clinical Trial Leadership & Oversight

  • Lead and manage all aspects of clinical trial execution from site activation through study close-out.

  • Provide oversight of site management, clinical monitoring, and central monitoring activities to ensure compliance with protocol, ICH-GCP, SOPs, and regulatory requirements.

  • Identify, assess, and mitigate operational, quality, and compliance risks, including contribution to the Risk Assessment and Categorization Tool (RACT).

Operational & Financial Management

  • Review study scope of work, budgets, and protocols, ensuring clinical teams understand contractual obligations and delivery parameters.

  • Monitor trial progress using operational metrics, dashboards, and reports to proactively identify risks related to timelines, quality, and cost.

  • Escalate out-of-scope activities and delivery risks to project leadership with proposed mitigation strategies.

Cross-Functional Collaboration

  • Partner with Study Start-Up, Data Management, Patient Recruitment, Pharmacovigilance, Medical Monitoring, and Quality Assurance teams to ensure seamless handoffs and milestone achievement.

  • Review and provide operational input into functional plans such as Data Management Plans and Communication Plans.

  • Serve as a key point of escalation for investigator sites, including direct interaction with principal investigators when required.

Systems, Documentation & Quality

  • Develop and maintain clinical study tools and documentation, including Clinical Monitoring Plans.

  • Ensure accurate and timely use of clinical systems such as CTMS, EDC, ePRO, eDiary, TMF, IVRS/IWRS, and central monitoring platforms.

  • Review and approve monitoring documentation to ensure accurate representation of site activities, risks, and compliance issues.

  • Support inspection readiness and audit activities across assigned studies.

Team Leadership & Mentorship

  • Oversee CRA and Central Monitor resourcing, performance, training compliance, and quality of deliverables.

  • Provide performance feedback to line managers and support corrective and preventive action planning.

  • Mentor and coach Clinical Trial Managers and team members on risk management, operational execution, and best practices.


Required Qualifications & Experience

Education

  • Bachelor’s degree or Registered Nurse qualification in a life sciences or related discipline.

  • Equivalent combination of education, training, and experience will be considered.

Experience

  • Clinical Trial Manager II: Minimum 5+ years of experience in clinical trial operations, monitoring, or study management.

  • Senior Clinical Trial Manager: Minimum 7–10 years of progressive experience managing global clinical trials, including leadership of complex or high-risk studies.

  • Demonstrated experience in site management and clinical or central monitoring.

  • Prior experience with risk-based monitoring models is strongly preferred.

Technical & Regulatory Knowledge

  • Strong knowledge of ICH-GCP guidelines and global regulatory requirements.

  • Solid understanding of clinical trial financial principles, budgeting, and resource planning.

  • Proficiency with clinical trial systems and standard business applications.

Core Competencies

  • Proven leadership and team alignment skills in global, matrixed environments.

  • Strong problem-solving, risk management, and decision-making capabilities.

  • Excellent communication, stakeholder management, and conflict resolution skills.

  • Ability to operate effectively in an international and cross-functional setting.

Travel

  • Moderate travel may be required, approximately 20%, depending on study needs.


Why Join Syneos Health

  • Work on high-impact global clinical trials supporting innovative therapies.

  • Flexible hybrid or home-based work model.

  • Strong commitment to career development, learning, and internal progression.

  • Inclusive culture focused on collaboration, integrity, and patient outcomes.

  • Trusted partner on the majority of newly approved FDA and EMA therapies.


Additional Information

This job description is not exhaustive and may be modified to meet evolving business needs. Syneos Health is an equal opportunity employer and complies with all applicable employment, equality, and accessibility legislation.


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