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Clinical Trial Manager I

0-2 years
Not Disclosed
10 May 2, 2025
Job Description
Job Type: Remote 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

 

Job Title:

Clinical Trial Manager I


Company:

Syneos Health
A global biopharmaceutical solutions organization specializing in accelerating customer success by providing integrated clinical, medical affairs, and commercial services.


Location:

Portugal (Europe)


Job ID:

25003425-PRT


Updated:

Today


Job Summary:

The Clinical Trial Manager I will oversee the clinical monitoring, site management, and risk mitigation for clinical trials. The role involves ensuring regulatory compliance, managing risks, and collaborating with cross-functional teams to ensure successful trial delivery, meeting key milestones and project goals.


Key Responsibilities:

  • Oversee site management, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol compliance, and data integrity.

  • Manage post-activation site interactions, including recruitment and investigator payments.

  • Identify and mitigate protocol execution risks using the Risk Assessment and Categorization Tool (RACT).

  • Review the study scope of work, budget, and protocol content to ensure alignment with clinical project team objectives.

  • Address risks related to clinical trial deliverables (timeline, quality, budget) and escalate issues as needed.

  • Lead key meetings, including Kick-Off, and provide solutions for obstacles in trial execution.

  • Collaborate with other functional leaders to meet study milestones like site activation, enrollment, and database lock.

  • Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan.

  • Provide training on protocol specifics, CRF completion, data plans, and SOPs to the study team.

  • Oversee clinical resources, including CRAs and Central Monitors, and ensure quality in deliverables.

  • Track progress using clinical trial systems (CTMS, EDC, IVRS, etc.) to monitor study execution and compliance.

  • Manage communication with investigators and other site staff, resolving issues as needed.

  • Ensure inspection readiness and support corrective action plans for study risks.


Qualifications:

  • Required:

    • Bachelor’s degree or RN in a related field or equivalent education/experience.

    • Experience in clinical trial site management.

    • Familiarity with risk-based monitoring, Good Clinical Practice (GCP), ICH Guidelines, and applicable regulatory requirements.

    • Strong communication, problem-solving, and conflict resolution skills.

    • Ability to apply critical thinking to resolve complex issues and manage study risks.

    • Good computer skills and proficiency in project management tools.

    • Moderate travel requirement (approximately 20%).

  • Preferred:

    • Experience with clinical or central monitoring and budget management.


Why Syneos Health?

Syneos Health offers a dynamic and inclusive work environment where employees can thrive through career development, recognition, and a supportive company culture. Join a global team that drives progress in clinical research.