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    Study Manager

    Aequor
    3-5 years
    Not Disclosed
    Princeton Junction
    15 June 12, 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, 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 Description: Clinical Trial Manager

    Company Information

    Employer: Aequor
    Location: Princeton, New Jersey (NJ), United States
    Job Code: 24-01569
    Post Date: 05/30/2024

    Summary

    The Clinical Trial Manager is responsible for planning and executing one or multiple global trials. This includes managing all aspects of trial deliverables such as timelines, budgets, recruitment, country/site selection strategies, and provision of clinical trial materials. The role serves as the main contact for cross-functional teams, CROs, vendors, and study sites.

    Requirements

    • Education: Bachelor’s degree in biological sciences or equivalent.
    • Experience: 3-5 years of relevant clinical trial management and leadership experience in the pharmaceutical, biotechnology, CRO, and/or healthcare industry.
    • Skills:
      • Excellent communication skills.
      • Command of medical terminology.
      • Knowledge of scientific/medical and clinical concepts used in Phase I-IV clinical trials.

    Responsibilities

    Trial Management

    • Plan and execute global trials, managing all aspects of trial deliverables.
    • Develop timelines, budget, recruitment, and country/site selection strategies.
    • Provide clinical trial materials.
    • Serve as the main study contact for cross-functional teams, CROs, vendors, and study sites.
    • Monitor KPI and performance metrics, drive related discussions, and escalate risks/issues.
    • Report status to the clinical operation lead.

    Documentation and Protocols

    • Participate in the preparation of protocols and Case Report Forms (eCRFs).
    • Author and coordinate study-specific documents such as Informed Consent.
    • Ensure compliance with the project plan and mitigate potential risks and issues.

    Collaboration and Training

    • Work with CROs to develop processes and mitigation strategies.
    • Collaborate with Clinical Development and CRO on study-specific training for study teams and sites.

    Financial Management

    • Responsible for the financial management of the clinical trial.
    • Monitor trial milestones and day-to-day operations, ensuring accurate information in internal electronic systems and reports.

    Participant Recruitment and Data Management

    • Ensure timely recruitment of trial participants and efficient data management.
    • Oversee systems to track study, investigator, and ethical review board information, patient recruitment activity, and financial management.

    Site Management

    • Lead site identification and selection in collaboration with internal medical leads and CROs.
    • Verify qualifications and resources of research staff and facilities.
    • Ensure proper setup of study sites with trial materials, investigational products, and training.

    Compliance and Quality Assurance

    • Verify adherence to the approved protocol, SOPs, GCP procedures, and regulatory requirements.
    • Provide oversight of study CROs and vendor activities, including creating and managing CRO oversight plans.
    • Ensure inspection readiness of trial documentation and support Quality Assurance on site audits, CAPA, and inspection requests.

    Meetings and Coordination

    • Manage and coordinate investigator meetings and cross-functional team meetings.
    • Lead selection, setup, and provide oversight to study vendors such as IRT, ePRO, ECG, Central lab, etc.

    Additional Information

    Aequor is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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