• Sr Clinical Data Coordinator

    Job Locations (All) | US-PA-Blue Bell | US-NJ
    Posted Date 1 week ago(1/11/2019 12:07 PM)
  • Overview

    Position Overview:

    Under the direction of the applicable management, the Encoder (ENC) is responsible for executing activities pertaining to the encoding of clinical trial data, including but not limited to: supporting the Manual Encoding Leads in data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with Merck Standard Operating Procedures (SOPs) and ICH-GCP guidelines.


    Primary activities include, but are not limited to: 

    • Accountable for all trial level clinical coding
    • Interact and communicate with customers and stakeholders both internal and external to GDMS as well as Sponsor when needed.
    • Support the Manual Encoding Leads, as needed, with GDO responsibilities to design, create, validate, review, approve and maintain encoding specifications.
    • Working with InForm/ Central Coding/TMS systems
    • Coding with MedDRA and WHODrug
    • Participate in relevant operational meetings.
    • Execute and trigger communications and escalations at the protocol level within department, within function and cross-functionally.
    • Execute and maintain adherence to a metrics control plan and quality assessment indicators at the trial level.
    • Support the database lock and interim analysis activities related to encoding.
    • Accept and execute special responsibilities related to process maintenance, data quality assessment, and staff training.
    • Continually monitor for opportunities to improve efficiency, effectiveness and quality.
    • Performs tasks with minimal guidance from Manager(s).



    Associate Degree, RN (or higher) in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline

    Knowledge and Skills:

    1. Excellent Oral and written English language skills.
    2. Knowledge of regulations and policies applicable to the pharmaceutical industry encoding.
    3. Understanding of the clinical development process and the value of encoding.
    4. Knowledge of clinical practice and medical terminology.
    5. Ability to work cross functionally and as part of a team.
    6. Be able to work under pressure in a changing environment with flexibility.
    7. Ability to work independently and accept and act with appropriate accountability with minimal guidance by a manager.
    8. Ability to coordinate the work of others and influence decision making.
    9. Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas.
    10. Exceptional organizational and problem-solving skills.

    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.


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