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Job Details

Clinical Database Builder

Company: Synteract
Location: United States Anywhere, US None
Reference: 27826
Closing Date: 14 Jan 19
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Clinical Database Builder - anywhere US remote   Who We Are Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ”Bringing Clinical Trials to Life,” we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and...

Requirements:

Clinical Database Builder - anywhere US remote   Who We Are Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ”Bringing Clinical Trials to Life,” we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare.   Position Overview The Clinical Database Builder is responsible for Case Report Form (CRF) development and clinical study database build in accordance with the Clinical Data Management System (CDMS) guidelines and Synteract standards for CRF development and study build.  S/he ensures on-time delivery and communicates the status of projects to internal teams.   Specific tasks would include:

  • Performs, or assists with, the validation of clinical study databases.
  • Provides support for user account administration for all in-house Clinical Data Management Systems (CDMS), including Rave.
  • Implements and QC‘s efficient Electronic Data Capture (EDC) clinical databases; building per specifications provided by Data Managers.
Qualifications
  • Bachelor’s degree in a relevant field of study and 1-3 years related work experience inclusive of or equivalent combination of education, certification, and experience.
  • Must have experience building from a protocol
    • Basic understanding of CDISC and CDASH standards is required.
    • Strong understanding of clinical trial documents (protocols, data management plans, CRFs, study reports) and processes required.
  • Fundamental understanding of data management practices and clinical data management systems (CDMS).
  • Fundamental understanding of Clinical Trial processes, specifically as they are related to data collection and management.
  • Solid practical experience working with Medidata Rave eCRF building.  Marvin and Medrio a plus.
  • Fundamental understanding of data capture / data reporting and industry standards
  • Fundamental understanding of 21CFR11, HIPAA and computerized systems validation.
  • Proficiency in Microsoft Office; Word, Excel, PowerPoint, Outlook as required.
  • Basic proficiency in graphic programs such as Adobe Framemaker and Adobe Acrobat a plus but not required.
  • Effective verbal and writing skills; English + local language, if relevant.
  If you’re passionate about bringing clinical trials to life, we encourage you to apply today!  Please apply online stating your earliest start date/notice period and your desired salary.   Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Candidates must possess current and valid authorization to work in the country to which they are applying.

Apply for this job: Clinical Database Builder

Contact Information:

Address:  SynteractHCR Deutschland GmbH
Albrechtstrabe 14
80636 Munich
Germany
Tel:  +49 89 12 66 80 0
Fax:  +49 89 12 66 80 2444
Website:  Visit Our Web Site

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