Company

KCR

Advertisement

Clinical Data Manager (PL)

City/voivodeship

Warsaw

Publication

2017-05-17

Company description

KCR is a contract research organization providing clinical development solutions for the pharmaceutical, biotechnology and medical device industries.
The company supports clients with full-service capabilities across three main services: Trial Execution (TE), Functional Service Provision (FS) and Trial Execution Consulting (TC) over a broad range of therapeutic areas. 
KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe with hubs located in Boston, U.S., Berlin, Germany, Warsaw, Poland and Kiev, Ukraine. KCR’s geographical locations allow for optimized delivery of trial execution strategies to develop life-changing therapies. For more information visit www.kcrcro.com.
KCR: We see human behind every number
A leading Clinical Research Organisation (CRO), with over 20 years of presence on the international market, operating across 27 countries is seeking to employ experienced Clinical Data Manager.
The new incumbent shall take full accountability for coordinating and performing the collection of CRF data.
This is a permanent position based in one of the company’s Operational Hubs in Warsaw (PL).
Location: Warsaw (office-based)

The duties associated with the role include:

  • Coordinating and performing the collection and processing of CRF data
  • Performing data management activities, including: data receipt, data entry, and initial and final data review, and discrepancy resolution
  • Using manual and automated methods to perform clinical data review and medical review to ensure the overall integrity and consistency of the clinical trial data
  • Encoding unrecognized terminology entered into the database using MedDRA and other dictionaries
  • Identifying and resolving central and local data quality issues and maintaining standard central and local data management practices
  • Coordinating and performing DM set-up process, CRF/eCRF set-up, collector design, edit definitions, report requirement definition, requirement documentation and testing
  • Ensuring consistency in execution across assigned trial portfolio
Requirements:
  • University/college degree in paramedical or technical discipline
  • A minimum of 5 years of experience in clinical data management, clinical research or in a clinical or bio-medical area
  • Excellent English skills (both written and verbal) as well as strong communication and interpersonal skills, with an ability to work cross functionally in a globally diverse environment
  • Strong computer skills, with preferred experience in one or more EDC tools and with basic knowledge of late stage clinical development process
  • Excellent knowledge of ICH/GCP, including understanding of regulatory requirements and European Directives
  • Other desired characteristics include good organization, analytical and presentation skills along with the ability to work independently and efficiently
 
At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits
that comply with national regulations and provide the coverage that best meets employee needs.
To show that you are appreciated in our team, while working at KCR you will be provided with: 
  •  3-step onboarding process to enable you fast takeover of duties
  •  Peer Buddy Mentor who will introduce you to the organization
  •  Friendly office space, coffee, tea and sweets
  •  Flexible, remote working options
  •  Time off – additional days of holidays for birthday, leaves of absence
  •  Loyalty bonus for long term cooperation
  •  Employee referral program
  •  Empowering workspace, offering opportunities to share ideas and influence company services development worldwide
  •  Open culture based on our values: knowledge, customer focus, accountability, commitment, tenacity and determination to succeed
  •  Mentoring and training programs related with clinical trials, therapeutic areas, soft skills development
If you wish to apply, please submit your CV using the button below.