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    Clinical Project Manager / Scpm (Mandarin Required)

    Caidya
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 4, 2024
    Job Description
    Job Type: Full Time Remote 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

    Job Title: Project Manager or Senior Project Manager
    Location: Remote – United States or Canada

    Special Note: Fluency in both Mandarin and English is required.

    Job Overview:
    The Project Manager is responsible for managing clinical trials to ensure the timely delivery of project objectives and adherence to client agreements and budgets. This role includes ensuring compliance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), ICH guidelines, and other relevant regulations. The Project Manager serves as the primary liaison with clients, facilitating effective communication regarding project progress and resolutions to any issues that arise.

    Key Responsibilities:

    • Develop clear and measurable project management plans in collaboration with the Director of Clinical Operations and Sponsor representatives.
    • Manage clinical projects to ensure deliverables from all functional areas meet contractual timelines and quality standards.
    • Define timelines, milestones, and scope of work for project staff.
    • Establish project metrics and reporting schedules, providing regular updates to clients.
    • Act as the primary liaison between the project team and sponsors/customers.
    • Identify critical success factors for tracking and analyzing project risks.
    • Monitor project status, budget expenditures, and recommend solutions for identified issues.
    • Coordinate resource assignments and ensure adequate staffing to meet project goals.
    • Develop budget review strategies and implement cost containment measures.
    • Manage site contract and budget negotiations in line with project timelines.
    • Review and approve project grants, expense reports, and financial records.
    • Oversee the development and delivery of project team training.
    • Set and communicate performance expectations and guidelines for the team.
    • Manage service provider performance, delegating assignments to encourage growth and responsibility.
    • Participate in the development and review of departmental SOPs and continuous process improvement initiatives.
    • Support business development by participating in proposal development and representing Caidya at professional meetings.

    Supervisory Responsibilities:

    • No direct supervisory responsibilities, but may mentor team members.

    Job Requirements:

    Education:

    • Bachelor’s degree preferred; advanced degree or equivalent clinical research experience is a plus.

    Experience:

    • Minimum of 2+ years managing clinical trials as a Clinical Project Manager or similar role at a CRO.
    • 5+ years in the clinical research industry.

    Skills/Competencies:

    • Expertise in project management with a proven ability to manage projects and teams effectively.
    • Strong problem-solving skills and adaptability in a fast-paced environment.
    • Extensive knowledge of clinical research and the drug development process.
    • Strong written and verbal communication skills, capable of maintaining positive relationships with sponsors and team members.
    • Proficient in MS Office suite and project management software.
    • Demonstrates professionalism and integrity, fostering teamwork and flexibility.

    Capabilities:

    • Fluent in English and Mandarin, both verbal and written.
    • Infrequent travel may be required.

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