Covance

  • Centralized Trip Report Reviewer II (Clin Ops)

    Job Location(s) IN-Mumbai
    Job Number
    2019-35282
    Job Category
    Clinical Operations Entry Level
    Position Type
    Full-Time
  • Job Overview

    Job location: Mumbai, India

     

    Job Responsibilities:

    •Act as an SME and lead initiatives
    •Thought Leader in providing Industry trends
    • Ability to Influence stakeholders
    • Mentor Delivery teams and cross departmental synergiesDemonstrated ability to plan, prioritize, organize and communicate effectively.
    • Demonstrated ability to pay attention to detail.
    • Strong interpersonal skills with ability to work well with others.
    • Ability to deliver consistent high quality of work.
    • Ability to use computer and departmental tools.
    • Strong interpersonal skills.
    • Ability to negotiate/Influence with others.
    • Ability to train others.

     

    Essential Job duties:

     

    1. Management of complex projects under direction of a Project Manager / Director as assigned.
    2. Ensure site monitoring responsibility for clinical studies are conducted according to Covance Standard Operating Procedures, ICH Guidelines and GCP.
    3. Work Closely with project teams in implementation of best TRR practices & applicable project plans as assigned(Implementation of Initiatives either independently or with team)
    4. Proactively identifies opportunities for process improvements and work collaboratively with project team incase further action required
    5. Complete required trainings according to required timelines.
    6. Follow applicable departmental Standard Operating Procedures and Work Instructions.
    7. Proactively identifies opportunities for process improvements. Leads the process improvement opportunities and manages the implementation of associated revised processes and procedures.
    8. Follow project issue escalation process and Covance Corrective Action Issue Resolution (CAIR) process for clinical operations issues
    9. Ensure follow up on issues and risks and protocol deviations and to be a liaison between CRA, CTL and PM for timely resolution of issues
    10. Responsible for the timely and appropriate communication to the clinical operations team
    11. Liaise with CTL/PM to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety.
    12. Review progress of project and initiate appropriate actions to achieve target objectives assigned.
    13. Leading the team of TRRs on projects and ensuring that the entire trip report team is following the same standards of quality review. As Lead TRR also to be the main point of contact for communication with the Global CTLs/PMs.
    14. Mentoring and training of new TRRs on trip report processes as per ICH-GCP and in house SOPs and local work instructions
    15. Performing quality check of the work of new TRRs as a part of mentoring.
    16. Review and support development of training material and plans to support the training requirements of the department.
    17. Ensure training resources are kept up to date with changes in procedures 18. Other duties as assigned by management: e.g Document Review, ETMF reconciliation, other CTL tasks etc.

     

    Education:

    University/ College Degree - Lifesciences preferred or certification in a related allied health profession from an appropriate accredited institution.

    Preferred - Master or other advance degree

     

    Education/Qualifications

    University/ College Degree - Lifesciences preferred or certification in a related allied health profession from an appropriate accredited institution.

    Preferred - Master or other advance degree

     

    Experience

    Individual should be proficient with on site monitoring activities (including pre studies, initiation, routine monitoring and close out visits.

    Minimum of 4 years of relevant clinical research experience in a pharmaceutical or CRO.

    Thorough knowledge of drug development process.

     

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