Opening for the post of Clinical Data Associate - Trainee @ Clinipace
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Clinipace Worldwide is a different kind of CRO, where people are the backbone of our technology-amplified processes.  We are a global full-service digital Clinical Research Organization (dCRO) and one of the fastest growing companies in America.  Clinipace currently has a global footprint of 12 offices in eight countries.  Our proprietary technology (TEMPO™ eClinical platform) combined with an innovative service model transforms drug and medical device development.  We are proud to have a culture that is vibrant, supportive, performance-driven, and passionate while focusing on continual learning and development.  Our associates are passionate about their lives and bring that same passion to their work at Clinipace Worldwide.


Location:     Trivandrum, India
Job Code:     M1217-1
Description

The Clinical Data Associate Trainee assists the Clinical Data Manager with the process of cleaning and validating data in clinical trials in accordance with Clinipace Worldwide SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements.

Locations preferred: Trivandrum, India (Office based)

Job Duties and Responsibilities for the Clinical Data Associate:

The specific job duties of a Clinical Data Associate may include but are not limited to:

    Assists with reviewing and processing Data Clarification Forms, reviewing data listings and quality control reports and updating clinical databases.
    Assists with Data Entry and Reconciliation as needed or assigned.
    Assists with start-up activities including:
        Creation and entry of test data for data entry screen validation
        Set up of patient and investigator information
    For specified projects assists on some data management activities as detailed below and performs activities in accordance with our SOPs, Good Clinical Practice, ICH Guidelines and study documentation.
        Study status tracking
        Data Entry
        Review of data listings
        Identification of data issues and query generation
        Updating of database with query resolutions (on paper studies only)
        Archiving of critical documents on an ongoing basis
    Assists with maintaining and updating Data Management Plans and any other relevant Data Management Documentation.
    Participates in assigned study finalization activities including:
        Database close-out
        Reconciliation
        Critical item review
        Quality Control
        Archiving.
    Participation in appropriate project team meetings.
    Manages time in accordance with allocated hours for task.
    Participates in departmental and organizational meetings and initiatives.

Supervisory Responsibilities:  No supervisory responsibilities.

Job Requirements for the Clinical Data Associate:

    Education
        College graduate with  a life science, computing or nursing qualifications  preferred, or 3 to 4 years equivalent experience
    Experience
        Experience with medical terminology preferred.
    License/Certification
        N/A
    Skills/Competencies
        Excellent organizational skills
        Strong written and verbal communication skills
        Exceptional attention to detail
        Strong computer skills, including Microsoft Office
        Good problem-solving skills
    Capabilities
        Flexibility - willing to change assignments and work focus to accommodate project demands
        Team player – effective proactive participant as a team member.
        Work evening and/or weekends on occasion as needed by the project
Click here to apply

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