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    International Ctm, Fsp, Client-Dedicated, Home-Based, Germany

    Syneos Health
    3+ years
    Not Disclosed
    Remote - Europe
    10 Nov. 29, 2024
    Job Description
    Job Type: Full Time Education: PhD/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

    International Clinical Trial Manager (CTM)

    Functional Service Provider (FSP), Client-Dedicated
    Location: Home-based, Germany

    Role Overview

    As an International CTM, you will play a pivotal role in the planning and execution of Phase 1–4 clinical research studies. This role emphasizes site management, vendor oversight, and ensuring that clinical trials are conducted efficiently, on time, and in alignment with quality standards. Working as part of a collaborative team, you will support critical trial components while sharing responsibilities with another project manager.

    This position is part of the Syneos Health FSP 360 team, designed to meet the unique goals of our clients.

    Key Responsibilities

    Study Planning and Execution

    • Oversee one or more elements of clinical studies while adhering to ICH/GCP standards, global regulations, and client policies.
    • Support the Study Project Manager (SPM) in coordinating cross-functional study teams and preparing Clinical Study Team meetings (e.g., agenda and minutes).
    • Provide regular study updates to teams and stakeholders, ensuring CTMS systems are current.

    Clinical Trial Operations

    • Contribute to the development and review of study blueprints, protocols, and related documents (e.g., informed consent forms, eCRFs, IRT specifications).
    • Manage investigator site selection processes, feasibility assessments, and green light procedures.
    • Support financial and contract negotiations, including budget creation, site contract amendments, and vendor payments.
    • Ensure effective vendor selection and oversight, developing and managing vendor oversight plans.

    Training and Compliance

    • Assist in creating study-specific and site-level training materials, facilitating training sessions as required.
    • Collaborate with teams to organize investigator meetings and ensure all study staff receive appropriate training.
    • Maintain TMF health and compliance, ensuring timely updates, reconciliations, and archival.

    Monitoring and Risk Management

    • Develop and maintain risk assessment and mitigation plans throughout the study lifecycle.
    • Drive issue management and resolution, ensuring adherence to regulatory and protocol requirements.
    • Oversee the labeling, shipment, and reconciliation of investigational products and clinical supplies.

    Key Qualifications

    Education and Experience

    • Bachelor’s degree in life sciences, pharmacy, medicine, or related field (advanced degrees like MSc/PhD are preferred).
    • Significant experience leading interventional trials independently across multiple countries, particularly in vendor management (e.g., labs, IVRS).
    • Fluency in German and English is mandatory.

    Skills and Knowledge

    • In-depth understanding of clinical research phases, ICH/GCP guidelines, and local/global regulatory frameworks.
    • Strong IT skills, including proficiency in MS Office and clinical applications.
    • Demonstrated ability to analyze data, manage timelines, and resolve issues proactively.

    Preferred Attributes

    • Excellent communication, presentation, and interpersonal skills.
    • Previous CRA experience is advantageous but not required.
    • Hands-on expertise in managing budgets, contracts, and study documentation.

    What Syneos Health Offers

    • Flexible Work: Home-based role with adaptable working hours for optimal work-life balance.
    • Manageable Workload: Oversee 1–2 international trials at a time, with task-sharing among team members.
    • Global Impact: Work on groundbreaking clinical trials with a leading global pharma client.
    • Competitive Benefits: Permanent full-time contract and comprehensive rewards package.

    How to Apply

    Take the next step in your clinical research career and apply now. Alternatively, join Syneos Health’s Talent Network to stay informed about future opportunities.

    At Syneos Health, we encourage candidates with diverse experiences and transferable skills to apply. We are committed to fostering an inclusive, authentic, and collaborative workplace.

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