Clinical Data Manager
Labcorp Drug Development
Madrid, Spain
hace 5 días

Job Overview :

Labcorp is a global, world-leading Life Sciences Contract Research Organisation that provides dedicated and fully comprehensive laboratory testing and drug development services to the pharmaceutical industry.

We strive to make a difference to people’s everyday lives by bringing essential medicines to the market.

At Labcorp we are looking to expand our Global Data Management team and we are hiring an Clinical Laboratory Data Manager.

The position can be located in UK, Switzerland, Spain or in Belgium.

The main responsibilities include :

  • Engage client data management during start up activities which includes :
  • Contact clients for initial study discussion and determine authors of Data Transfer Specifications (DTS). Provide recommendations and alternatives to optimize data quality
  • Review Statement of Work (SOW) for study scope.
  • Ensure start-up packet delivery to clients.
  • Collaborate with clients to finalize Data Transfer Specifications and obtain final client approval on Data Transfer Specifications (DTS
  • Create standard data transfer format(s) in compliance with client requests while adhering to both internal processes and regulatory standardsBuild and modify Data Transfer formats, including creation of test data as needed.
  • Perform Quality Check (QC) test files, and deliver test files to clients Obtain client approval and store auditable documentation.

  • Provide ongoing client support (study maintenance) which includes : Participate in study-related meetings.Collaborate with clients regarding study modifications, and new service requests.
  • Confirm changes and send files as needed.Address errors and client issues including queries.Collaborate with Project Management proactively and reactively regarding study questionsFacilitate Data Management functions of end-to-end data lock processes.

    Maintain auditable documents.

  • Partner with other Covance departments and business units, and provide integrated support and process improvements as needed.
  • Represent Global Data Management in client visits, audits, inspections and bid defenses as needed.
  • Education / Qualifications :

  • BS / BA four-year degree or equivalent education, or 4 years Labcorp experience
  • Experience :

  • Customer Service experience.
  • Data Management and / or Clinical Trials experience.
  • Pharma and / or health industry experience preferred
  • Ability to use standard Microsoft suite of software products.
  • Conversant with databases and database terminology.
  • Strong technical aptitude.
  • 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.
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