General Information

Location: Hamilton Township, NJ

Organization: MedAvante-ProPhase

Job Type: Full Time

Description and Requirements

SUMMARY OF POSITION: 
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. 

QUALIFICATIONS/EXPERIENCE
  •  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/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.
  • 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 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. 

ABOUT US:
MedAvante-ProPhase, a subsidiary of WIRB-Copernicus Group (WCG) 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 on of Pharma's most intractable problems: the bias and variability that caused 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.