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    Associate Clinical Operations Leader

    Parexel
    2+ years
    Not Disclosed
    Remote
    10 Oct. 30, 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, 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

    About this Role

    Key Responsibilities:

    Effective Communication:

    • Engage with internal and external customers, as well as third-party vendors.
    • Prioritize urgent requests from the team or sponsors promptly.

    Project Initiation & Planning:

    • Manage study start-up activities and provide input for project tools, PM plans, and Central File Maintenance Plans.
    • Contribute to the format and content of sponsor reports and oversight of site selection strategies.
    • Support the development of site selection and monitoring plans, patient recruitment, and retention plans.
    • Ensure all team members have access to necessary tools and documents.
    • Establish efficient working relationships with other functional leaders and coordinators.

    Project Implementation, Control & Evaluation:

    • Lead and direct project team members, providing training and support in collaboration with Project Leaders.
    • Monitor resource utilization throughout the project lifecycle, providing productivity targets and performance feedback.
    • Address site issues promptly and support the early recognition of potential problems with contingency plans.
    • Oversee study timelines, patient recruitment, retention, and data cleaning for successful project outcomes.
    • Maintain quality of work generated and support process improvements.

    Project Close-out:

    • Collaborate on database lock activities and ensure completion of administrative closeout procedures.
    • Ensure project documentation is archived and returned to clients as per contract specifications.
    • Participate in end-of-study meetings to discuss lessons learned.

    Operational Responsibilities:

    • Maintain knowledge of and compliance with ICH-GCP guidelines, regulatory requirements, and internal SOPs.
    • Complete routine administrative tasks (e.g., timesheets, metrics, expense claims) in a timely manner.

    Skills

    Leadership Skills:

    • Ability to lead a virtual team across locations and cultures.
    • Effective prioritization and direction of project tasks.
    • Strong negotiation and influencing skills.
    • Proactive problem identification and resolution.

    Personal Skills:

    • Initiative and independence in task completion.
    • Team-oriented with a sense of urgency for high-quality work.
    • Excellent interpersonal, oral, and written communication skills.

    Business/Operational Skills:

    • Customer-focused with a commitment to quality.
    • In-depth understanding of the clinical trial process and project lifecycle.
    • Proficient in MS Office (Excel, Word, PowerPoint, Outlook, WebEx).

    Knowledge and Experience

    • Strong command of written and spoken English; local language proficiency as required.
    • Relevant experience in clinical research, preferably with CRA or substantial on-site monitoring experience.
    • Coordinating experience, ideally obtained in a Sr. CRA or Sr. CMA role.

    Education

    • Degree in a life science, nursing qualification, or relevant clinical/management experience.

    #LI-REMOTE

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