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Job Details

Clinical Data Coordinator

Company: SynteractHCR Deutschland GmbH
Location: United States Morrisville NC 27560
Reference: 27626
Closing Date: 16 Aug 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Clinical Data Coordinator - Morrisville, NC Office-based   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...

Requirements:

Clinical Data Coordinator - Morrisville, NC Office-based   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 Data Coordinator takes responsibility for tasks and processes, helping test the database, test edit checks, clean up data by reviewing Case Report Forms (CRFs), writing, sending, and resolving queries, and closure of the database. The Clinical Data Coordinator takes responsibility for tasks and processes, helping test the database, test edit checks, clean up data by reviewing Case Report Forms (CRFs), writing, sending, and resolving queries, and closure of the database   Specific tasks would include:

  • Reads and follows the Data Management Plan (DMP) for ongoing projects.
  • Assists in / coordinates CRF/Data Clarification Form (DCF) tracking, if applicable for the project.
  • May perform Quality Control (QC) activities related to database open.
  • May create test subjects for edit check validation and database export QC.
  • May provide appropriate personnel with the data conventions and guidelines for each specific project, ensures understanding and remains a resource throughout the project.
  • May perform data entry and/or verification tasks as necessary for assigned projects.
  • Addresses all issues relative to the clinical database with the Data Manager.
  • Reviews data, writes, resolves and modifies data discrepancies/queries.
  • Generates, formats, and edits data discrepancy reports.
  • May send queries to sites, Sponsor, and monitors, and communicate as necessary to help resolve queries.
  • Updates the clinical database following the query and resolution process.
  • May communicate with the Sponsor as needed regarding data/database issues, as directed by Data Manager or Data Management Oversight
  • May respond to requests or needs of the Sponsor during the course of the project, as directed by Data Manager or Data Management Oversight.
  • Learns sufficient SAS programming to produce simple reports.  May use SAS to review clinical datasets.
  • Produces reports, listings, and other output as required during the course of the project.
  • May export data from the clinical database to update the SAS database.
  • May assist in the creation of subject profiles to check data points against paper CRFs as part of the final database QC.
  • May coordinate activities related to coding and electronic data transfers, and address resulting discrepancies.
  • May assist in maintaining project documentation.
  • May assist in coordinating activities related to final database closure. 
  • Performs final Quality Control check of profiled clinical data against paper CRFs.
  • May assist with training end users on the applicable Clinical Data Management System, maintaining current system access and ensuring all training records are up to date.
  • May archive or assist in the archival of project documents.
  • May perform coding of medical terms/medications.
  • May provide operational and technical guidance and direction to colleagues.  
Qualifications
  • Bachelor’s degree in a life science or related field of study and 4+ years related experience or equivalent combination of studies, and/or work experience.
  • Completion of a Clinical Trials certification program is an asset.
  • Proficiency in Microsoft Office; Word, Excel, PowerPoint, Outlook as 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!    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. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.      #LI-CU1

Apply for this job: Clinical Data Coordinator

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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