Latest Jobs  
Advance your technical career… Find a tech school and start an IT career!
Start your career in the fast-growing technical field – Get more info here »
Advance your technology career with the latest technology skills - Get more info here »
 
This job has expired.
 
Job Information
Job title

Sr. Associate, Project Data Operations

Company Daiichi Sankyo
Wage between $0.00 - $0.00 Annually
Location United States, New Jersey, Edison
Employment type Full Time
Education Bachelor
Year Experience 1 - 2 Years of Practical Experience
Travel None
Published on 10/10/2007
Description
Job Summary:
Coordinates and administers the Daiichi Sankyo Clinical Data Repository (CDR) and other data and submission applications in support of projects to ensure the timely creation and maintenance of databases required by therapeutic projects; provide technical support for the operational aspects of data applications; provides training and maintenance of Daiichi Sankyo standards for data capture, storage, retrieval, reporting and submission; manages and monitors interactions with external vendors.

Responsibilities:
Supports the administration of data management and data submission applications including but not limited to the CDR, EDC, and WebSDM, ensuring that all submission data are captured and stored in a validated environment consistent with 21CFR Part 11. Responsible for oversight, maintenance and management of submission data (WebSDM) for all studies. Provide global Daiichi Sankyo and vendor user training to access and operate CDR.
Initiates and supports the development of standardization, training, and maintenance of CRF and eCRF modules, edit check specifications, data structures, data libraries, CDR Folder Structures, code lists, and dictionaries in conjunction with input from other functional areas and project teams.
Assists Project Data Operations Manager in identifying, documenting and tracking system enhancement and providing troubleshooting feedback to SAS Institute on SAS DD and other vendors on data management and data submission tools. Provide SAS DD and extension application system upgrade validation and User Acceptance Testing support.
Manages and coordinates the application of the CDR ensuring adherence to Daiichi Sankyo procedures and policies.
Demonstrates Daiichi Sankyo core competencies; exhibits Daiichi Sankyo values.

Education/Experience Requirements:

BA/BS in computer science, life sciences or related discipline
3 to 7 years Computer Information Systems/pharmaceutical/data management
Good oral and written communication skills
Microsoft Office Suite including Word, Excel, Access, Visio, PowerPoint and Project
Good problem solving, analytical, organization, and time management skills
Customer Focus, flexibility
Works well in a team environment
Knowledge of relational databases, database schemas, programming logic using various programming languages, including object-oriented languages.
Competence with GCP/regional regulatory guidelines, SOPs (including Standard Operating Instructions)
Familiarity with 21CFR Part11
Experience managing CROs and external vendors
Knowledge of CDMS, SAS, CDISC preferred
5% traveldf-tc

Experience/Skills
See Above

Other desired skills:
Sr. Associate, Project Data Operations
This job has expired.