Covance

  • Clinical Data Manager

    Job Location(s) CH-Geneva | BE-Mechelen
    Job Number
    2018-24271
    Job Category
    Other
    Position Type
    Full-Time
  • Job Overview

    Clinical Data Manager

     

    COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. 

     

    We are recruiting for our Data Transfer team and are currently seeking to hire a Clinical Data Manager to help support the team.

     

    This is a permanent full time position based in Meyrin/Geneva, Switzerland or Mechelen, Belgium

     

    About the Job

    Within this position, your duties will include:

    • Engage client data management during start up:
    1. Create protocol folder(s) for study documentation
    2. Add entries into individual protocol spreadsheet
    3. Review Statement of Work (SOW) for study scope
    4. Ensure start-up packet delivery to clients
    5. Contact clients for initial study discussion and determine authors of Data Transfer Specifications (DTS)
    6. Provide recommendations and alternatives to optimize data quality
    7. Collaborate with clients to finalize Data Transfer Specifications (DTS)
    8. Obtain final client approval on Data Transfer Specifications (DTS)
    • Act as a data liaison between Clinical Data Management and all other Covance departments and business units:
    1. Consult with Medical Affairs via a Med/Tech Affairs Request Form
    2. Collaborate with Project Management proactively and reactively regarding study questions
    3. Manage and resolve issues with Specimen Management
    4. Initiate data changes with the appropriate department and revise all non-compliant requests
    5. Partner with other Covance departments and business units, and provide integrated support and process improvements as needed
    • Create standard data transfer format(s) in compliance with client requests while adhering to both internal processes and regulatory standards:
    1. Build and modify Data Transfer formats as needed
    2. Create test data if needed
    3. Quality Check (QC) test files
    4. Deliver test files to clients and log into the metrics tool
    5. Obtain client approval and store auditable documentation
    • Provide ongoing client support (study maintenance):
    1. Create global transmission instructions
    2. Schedule appropriate frequency of data transfers
    3. Address errors and client issues including queries
    4. Participate in study-related meetings
    5. Collaborate with clients regarding study modifications
    6. Confirm changes and send files as needed
    7. Maintain auditable documents
    8. Facilitate Data Management functions of end-to-end data lock processes
    9. Represent Clinical Data Management in client visits, audits, inspections and bid defenses as needed
    10. Collaborate with clients regarding new service requests
    11. Support billing of services as needed

     

    • Attend training to increase Data Manager’s capabilities (including corporate, departmental and sponsor-related training).
    • Ensure uninterrupted client service:
    1. Support peers by sharing technical knowledge and customer service skills
    2. Back up peers as needed
    • Record data transfer activities and maintain protocol portfolios as required to track workload and productivity.

     

    About You

    To be successful in this position, you will need to be educated to a Degree level (or equivalent) in a relevant area or 4 years Covance experience.

    Additionally, you will need to demonstrate:

    • Strong organizational, planning and critical-thinking skills.
    • Well-polished, inclusive, and engaging communication skills (written and verbal).
    • Strong negotiation skills to facilitate, guide, influence, and produce a unified approach within a global, cross-functional environment.
    • Ability to handle multiple tasks in a timely and professional manner under demanding conditions.
    • Ability to use standard Microsoft suite of software products.
    • Conversant with databases and database terminology.
    • Strong technical aptitude.
    • Customer Service experience.
    • Data Management and/or Clinical Trials experience

    We Offer

    Covance offers a comprehensive benefits package including health cover, contributory pension and a competitive bonus scheme

    Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

    Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.

     

     

    Education / Qualifications

    To be successful in this position, you will need to be educated

    to a Degree level (or equivalent) in a relevant area.

     

    Additionally, you will need to demonstrate:

    • Strong organizational, planning and critical-thinking skills.

    • Well-polished, inclusive, and engaging communication skills

    (written and verbal).

    • Strong negotiation skills to facilitate, guide, influence, and

    produce a unified approach within a global, cross-functional

    environment.

    Ability to handle multiple tasks in a timely and professional

    manner under demanding conditions.

    • Ability to use standard Microsoft suite of software products.

    • Conversant with databases and database terminology.

    • Strong technical aptitude.

    Experience

    • Customer Service experience.

    • Data Management and/or Clinical Trials experience

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