JobWatch

1+ months

Clinical Data Manager

WIRB-Copernicus Group (WCG)
Hamilton, NJ 08609

General Information

Location: Hamilton, NJ

Organization: Medavante-Prophase, Inc.

Job Type: Full Time - Regular

Description and Requirements

This position is internally called a Clinical Data Scientist.  In this role, the Clinical Data Scientist will design, develop, and maintain key data management deliverables used to collect, review, monitor study information.  The clinical Data Scientist will also be responsible to ensure the integrity of clinical data, oversee application of standards, data review and query management, and is accountable for quality study data set release and consistency in asset/submission data. Furthermore, the Clinical Data Scientist is responsible for timely and accurate and reliable management of deliverables.  This position will work at our Hamilton NJ location.

Education Requirements:

  • Bachelors degree required; advanced degree preferred.

Qualification:

  • 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:   

  • Design, develop and maintain study data sets.

  • Create/Finalize Data Transfer Plans

  • 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 represent contributing the CDS department disciplines at external client meetings, investigator meetings, and business development opportunities.

  • Collaborate with sponsors and internal project manager 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.

  • Monitoring of data transfers for ongoing trials to identify study conduct and/or data quality issues.

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 Pharmas 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.

Categories

Posted: 2020-03-17 Expires: 2020-06-27

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Clinical Data Manager

WIRB-Copernicus Group (WCG)
Hamilton, NJ 08609

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast