• Start-up Specialist II

    Job Location(s) JP-Tokyo | JP-Osaka
    Job Number
    Job Category
    Clinical Operations
    Position Type
  • Job Overview

    Looking to start your career? Want to be part of a global leader in Clinical Services? Come join our Clinical Development Services operations. This is a senior associate level role for Regulatory Submission role in Japan. Come Join in Covance and create a great career!


    Top 3 Reasons You Should Join US!

    1. Merit-based Career Advancement: 33% of Covance Japan employees received promotion in 2016!! Many of us decided to join Covance Japan because we received career advancement right up front. Promotion depends purely on your ability, not on your age or just because you are with us longer than others.


    2. True Work-Life Balance: We believe your success at work depends on balance in your life. Some of our company benefits flexible work time (core hours 10:00am to 4:00pm) and work-from-home policy (PC and phone will be provided by company). As a result we have 100 % return rate from maternity leave, and some men are taking paternity leave. You do not feel guilty taking PTOs. Managers encourage their members to refresh after your job well done.


    3. Ground-floor Opportunity at a Growing Company: Covance Japan is still a young and growing company with energetic team members. What you say and what you do has huge impact on the entire company now, 3 years, and 5 years into the future. We also make sure we have fun while we work (monthly happy hour, Halloween costume party, Xmas party, family outings to BBQ etc.)!
    Develop your career in truly global life sciences company, helping to bring the miracles of medicine to market. Reach out to us for a coffee chat today!


    <Main Responsibilities>

    - Oversee timely collection of the required investigator and regulatory documents for a study as specified by regulatory authorities and sponsor.
    - Ensure the ongoing accuracy and quality of site/study documents.
    - Ensure high quality documents are filed in (e)TMF and systems are updated on an ongoing basis
    - Ensuring Covance is audit ready at any time.
    - Provide accurate projections and timelines to study teams based upon country’s historical
    performance and agreed with Sponsor.
    - Ensure project plans are followed for the Site Activation component of assigned studies,
    proactively engaging with key stakeholders to assure milestones are adequately represented and are being achieved and driving for solutions.
    - Participate in team meetings to report progress and challenges in trials. Identify potential risks to timelines and results and manage issues independently.
    - Liaise with Covance Regulatory department regarding document submission requirements, if applicable.

    - Monitor start up activities to ensure issues are identified, managed and, if necessary, escalated to the appropriate individual.

    - When needed review data for feasibility assessments at a country level.
    - Coach less experienced study team members as appropriate.
    - May be asked to negotiate timelines or delivery of project plan with SUPM’s under direction of senior specialist/SUCM

    - Perform other duties as assigned by management


    <Extended Responsibilities>

    - Review and customize country and site specific patient informed consents for compliance with local requirements and protocol.

    - Proactively resolve informed consent issues and other potential difficulties with study sites.
    - May negotiate contracts and budgets with investigative sites (via CRA) within parameters provided by SU PM and Sponsor.



    - University/College degree (life science preferred), or certification in a related allied health
    profession from an appropriate accredited institution (e.g., nursing certification, medical or
    laboratory technology) AND

    - 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.


    - > 4 years of experience in clinical development or regulatory process.
    - Significant experience of applying strong knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites

    - Significant experience of issue escalation and resolution.

    - Proven track record of effective communication and problem solving.
    - Experienced in creating and maintaining good business relationships

    - Proven ability to work under pressure with multiple internal clients with competing goals


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