General Information

Location: Hamilton, NJ

Organization: Medavante-Prophase, Inc

Job Type: Full Time - Regular

Description and Requirements

SUMMARY OF POSITION: The Clinical Data Scientist designs, develops, and maintains key data management deliverables used to collect, review, monitor, and the Clinical Data Scientist ensures the integrity of clinical data, oversees application of standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data. The Clinical Data Scientist is responsible for timely and accurate and reliable management deliverables.

EDUCATION REQUIREMENTS:

·         Bachelor’s degree required; advanced degree preferred.

QUALIFICATIONS/EXPERIENCE:

  • A minimum of 3-5 years Clinical Data Management experience required.
  • SAS experience in Clinical trials strongly recommended.
  • Experience with electronic Clinical Database Systems is required and experience with electronic reporting applications preferred.
  • Working experience with CDISC/SDTM standards.
  • Knowledge of GCP and 21 CFR Part 11 compliance is essential.
  • Detail oriented with a track record of problem solving and willingness to work in a dynamic environment.
  • Accuracy and ability to quality check all data deliverables.
  • Capable of creating presentations and presenting same at internal and external client meetings.
  • Expertise in the Microsoft suite, and knowledge of SPSS, SAS, or R required.
  • Good verbal and written communication skills.

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required.

  • Design, develop and maintain study data sets.
  • Create/Finalize Data Transfer Plans as well as create and deliver production and test data transfer files.
  • Review and quality check client data reconciliation and inform sites of remediation needed.
  • Participate in bid defense by supporting Business Development group in identifying business opportunities through the end of study.
  • Collaborate interdepartmentally by representing the CDS department disciplines at external client meetings, investigator meetings and business development opportunities.
  • Represent the CDS area by communicating with internal/external stakeholders: Internally and externally report CDS status, results and collected data.
  • Partner with sponsors and internal project managers to ensure that the database and CDS plans meet their requirements while adhering to the statement of work.
  • Coordinate deliverable schedules with study project managers.
  • Develop work instructions for new and existing systems and procedures.
  • Develop (and/or write requirements for) CDS reports/queries to enable/facilitate data monitoring across all operational systems.
  • Work with data owners (and QA) to document circumstances surrounding data discrepancies and solutions to address errors.
  • Identify areas for process improvements and implement solutions to increase quality, accuracy and efficiency of CDS processes.
  • Implement solutions for handling process changes – through existing or new system features; Run and review results of periodic/routine data checks.
  • Resolve/escalate production data issues by researching and identifying the root cause of the issue and working with appropriate resources to fix the issue.
  • Assist the CDS programmer in building SAS datasets from clinical database and in creating SAS edit checks
  • Monitor data transfers for ongoing trials to identify study conduct and/or data quality issues.
  • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.

SUPERVISORY RESPONSIBILITIES: The position will not require the individual to be responsible for the management, direction, coordination, performance, and evaluation of an assigned team and staff.

TRAVEL REQUIREMENTS: Ability to travel domestic and internationally, approximately 10% of the time, including overnight stays as necessary, consistent with project needs and office location.