General Information

Location: Hamilton, NJ

Organization: MedAvante-ProPhase

Job Type: Full Time - Regular

Description and Requirements

The Clinical Data Scientist (CDS) is responsible for managing and coordination of all data services on a given study. Working with the Project Manager and Clinical Scientist, the CDS will drive timelines and deliverables for all data science disciplines (Scales Management, eForms Services and Analytics).

Education Requirements:

  • Bachelor’s degree required, advanced degree preferred.

Qualification / Experience Requirements:

  • A minimum of 3 years of clinical data management experience required.
  • Experience with electronic Clinical Database Systems is required and experience with electronic reporting applications preferred.
  • Knowledge of GCP is essential.
  • Must be detail oriented with a track record of problem solving and willingness to work in a dynamic environment.
  • Must have good verbal and written communication skills.
  • Position requires the ability to quality check all data deliverables.
  • Ability to create presentation and present internally and external client meetings.
  • Knowledge of Microsoft Excel, SPSS, SAS, or R required.

Essential Duties and Responsibility:   

  • Manage all aspects of data transfers to sponsors/CROs: Draft/Finalize Data Transfer Plans; Create and deliver production and test data transfer files; and Assist in resolving sponsor/CRO data queries.
  • Participate in bid defense by supporting Business Development group in identifying business opportunities through the end of study.
  • Manage data within source database: Develop data conventions for entering, maintaining, cleaning data; Train system users in data conventions; and Learn assessment properties of clinical outcome measures, such as neurocognitive and adaptive ability scales, for assigned studies.
  • Collaborate interdepartmentally and represent the CDS department disciplines at external client meetings, investigator meetings, and business development opportunities.
  • Communicate with internal/external stakeholders: Internally and externally report CDS status, results, and collected data; Collaborate with sponsors and internal project manager to ensure that the database and DM plans meet their requirements while adhering to the statement of work;
  • Coordinate deliverable and non-deliverable documentation schedules with study project managers; and Work with data owners (and QA) to document circumstances surrounding data discrepancies and solutions to address errors.
  • Create and maintain documentation for data management processes: Develop work instructions for new and existing systems and procedures; Develop (and/or write requirements for) data management reports/queries to enable/facilitate data monitoring across all operational systems; and Work with data owners (and QA) to document circumstances surrounding data discrepancies and solutions to address errors.
  • Design and implement process improvements: Identify areas for process improvements and implement solutions to increase quality and efficiency of data management processes; Implement solutions for handling process changes – through existing or new system features; Run and review results of periodic/routine data checks; and Resolve/escalate production data issues by researching and identifying the root cause of the issue and working with appropriate resources to fix the issue.

Supervisory Responsibility:  None

About Us: 

MedAvante, a subsidiary of WIRB-Copernicus Group was founded in 2002 with the goal of helping to bring better drug therapies to market through smarter, faster clinical trials. With this goal in mind, MedAvante set out to solve one of Pharma’s most intractable problems: the bias and variability that cause failed or inconclusive trials for Central Nervous System (CNS) therapies. A few years later, MedAvante experts pioneered Central Ratings and introduced the concept of Central Review utilizing their groundbreaking Virgil eSource solution.