Clinical Data Analyst Intern
Parexel
Taipei, Taiwan
3天前

Job Description

  • Utilize current study documentation including protocol, Case Report Forms (CRFs), Cleaning guidelines etc.
  • Conduct in-house data review
  • Generate and close queries or apply self evident corrections to the data according to the relevant guidelines
  • Identify and report protocol violations
  • Manual and Patient Profile review, issue queries
  • Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action
  • Track and integrate queries
  • Perform clinical coding if appropriate to role within the project team
  • Ensure all documents coded for submission to central files
  • Lock site(s) within EDC system - remove user's data modification privileges
  • Interact with site (via mail) as required
  • Perform early and final database QC activities
  • Update all relevant tracking system on an ongoing basis
  • Inform responsible CDA coordinator of work status regularly
  • Keep manager informed about work progress and any issues to avoid surprises. Requires regular interaction / supervision by Manager or assigned mentor
  • Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements and PAREXEL WSOP and stud specific procedure
  • Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims
  • Skills

  • Excellent interpersonal, verbal and written communication skills
  • Excellent computer skills including but not limited to the knowledge of Clinical Trial / Data Management Systems, PMED, IVRS, MS-Office products such as Excel, Word.
  • Sound awareness of all relevant regulations, including GCP
  • Posses a thorough understanding of the various tasks related to project initiation, ongoing monitoring / processing and lock
  • Carefully weighs the priority of project tasks and directs team accordingly
  • Understands the strengths and development areas of team members
  • Ability to lead a 'virtual', global team as required
  • Gives others appropriate latitude to make decisions
  • Looks for win-win solutions to solve problems
  • Ability to make appropriate decisions in ambiguous situations
  • Ability to solve problems by using a logical, systematic, sequential approach
  • Communicate and work effectively with clients
  • Enlists the support of team members in meetings goals
  • Proposes new approaches, methods or technologies
  • Anticipates how others will react to situations
  • Effective time management in order to meet daily metrics or team objectives
  • Shows commitment to and performs consistently high quality work
  • Plans and delivers verbal and written communications that persuade the intended audience
  • Willing and able to travel as required ' local or international
  • Why Work at PAREXEL

    There are pivotal moments in every career : Sharing new treatments. Improving processes. Delivering life-saving advances.

    The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path?

    A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

    That’s Parexel. We’re a diverse team of professionals focused on one goal : getting treatments into the hands of those who need them most.

    Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

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