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Clinical Data Manager (Central Laboratory Services) in Geneva - Oferta z Jobs.pl

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  • AdresSwitzerland,
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Clinical Data Manager (Central Laboratory Services) in Geneva

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

    In Geneva Covance maintains a wholly-owned laboratory facility that employ the highest level of control to minimize variability and enhance data quality. Throughout these facilities, Covance uses the same methods, robust processes, and supplies. As a result, our clients benefit from consistent and combinable data.

    We are recruiting for our Clinical Data Management team in Geneva and are currently seeking to hire a Data Manager to help support the team. This is a permanent, full time position, based in our Geneva office.

    About the Job:

    Within this position, your duties will include:

    1. Engage client data management during start up.

    Create protocol folder(s) for study documentation.
    Add entries into individual protocol spreadsheet.
    Review Statement of Work (SOW) for study scope.
    Ensure start-up packet delivery to clients.
    Contact clients for initial study discussion and determine authors of Data Transfer Specifications (DTS).
    Provide recommendations and alternatives to optimize data quality.
    Collaborate with clients to finalize Data Transfer Specifications (DTS).
    Obtain final client approval on Data Transfer Specifications (DTS).

    2. Act as a data liaison between Clinical Data Management and all other Covance departments and business units.

    Consult with Medical Affairs via a Med/Tech Affairs Request Form.
    Collaborate with Project Management proactively and reactively regarding study questions.
    Manage and resolve issues with Specimen Management.
    Initiate data changes with the appropriate department and revise all non-compliant requests.
    Partner with other Covance departments and business units, and provide integrated support and process improvements as needed.

    3. Create standard data transfer format(s) in compliance with client requests while adhering to both internal processes and regulatory standards.

    Build and modify Data Transfer formats as needed.
    Create test data if needed.
    Quality Check (QC) test files.
    Deliver test files to clients and log into the metrics tool.
    Obtain client approval and store auditable documentation.

    4. Provide ongoing client support (study maintenance).

    Create global transmission instructions.
    Schedule appropriate frequency of data transfers.
    Address errors and client issues including queries.
    Participate in study-related meetings.
    Collaborate with clients regarding study modifications.
    Confirm changes and send files as needed.
    Maintain auditable documents.
    Facilitate Data Management functions of end-to-end data lock processes.
    Represent Clinical Data Management in client visits, audits, inspections and bid defenses as needed.
    Collaborate with clients regarding new service requests.
    Support billing of services as needed.

    5. Attend training to increase Data Manager's capabilities (including corporate, departmental and sponsor-related training).

    About You:
    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.
    Customer Service experience.
    Data Management and/or Clinical Trials experience.

    We Offer:

    The opportunity to work within an experienced and highly skilled team.
    Covance offers a comprehensive benefits package including health cover and a contributory pension.

    Covance's ongoing success offers team members unsurpassed growth and career development opportunities.
    At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.

    There is no better time to join us!

    Keywords:Clinical research, clinical data management, data management, CDM, CDARO, data management plan, ADaM, CRO, Clinical Data Management, Clinical Data Manager, Data Manager, CDM, Medidata, Rave.


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