at Silliker, Inc in LombardAddison, Illinois, United States
Job Description
Data Manager, Level 2
Addison
Regular
MERIEUX NUTRISCIENCES
As a trusted partner, our Public Health mission is to make food systems safer, healthier and more sustainable. Throughout our global network in 27 countries, we offer to our customers a wide range of testing and innovative solutions dedicated to preventing health risks related to food, environment and consumer goods. External growth has been a key pillar of our history with more than 40 acquisitions completed in the last 10 years.
If you want to contribute to an inspiring long-term purpose, to be part of a fast growing company on a high-value market with significant build-up opportunities, and to grow in an entrepreneurial and warm environment, join us!
YOUR DAY TO DAY LIFE
We are looking for a Data Manager, Level 2 in 800 S Rohlwing rd, Addison, IL 60101 USA. Your mission will be to:
Purpose (Objective):
This position makes significant contributions to all data management projects or tasks:Responsible for the delivery of timely, accurate, consistent and quality clinical data. The position identifies and implements solutions to data management issues and concerns, including proactive prevention strategies.
Main activities:
*Provides data management review of clinical research documents (e.g. Protocols, Case Report Forms, Reports and Statistical Analysis).
*Responsible for the development of Data Management Plan (DMP) for each clinical trial, follows DMP throughout the lifecycle of the study project and ensures DMP is followed according to study design and requirements.
*Serve as the project and sponsor liaison providing project specific data management status, timeline, and productivity metrics.
*Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications.Oversee all aspects of database clinical trial specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
*Ensures the successful and efficient development of Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
*Maintain productivity and quality indicators. Assist in the formulation of short-term and long-term strategies to improve project data management efficiencies, through collaboration with senior management.
*Responsible for staff training on study trials for EDC and create user guides.
*Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock.
*Define and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
*Responsible for the archiving of study databases and related documents. Ensure the required close-out audit is completed, as necessary.
*Coordinate and communicate with DB vendors on a consistent basis to address Clinical team requests, project plans, and/or eCRF development activities.Participate in conference calls and/or meetings with vendors.
*Responsible for collaboration with the IT and implementation team(s) to address clinical database requirements.
*Ensure data system compliance by following the established guidelines of national and international regulatory authorities.
*Maintain technical data management competencies via participation in internal and external training seminars.
*Identify areas for process and efficiency improvement and implement solutions on assigned projects.
*Support development of global, harmonized SOPs and specific quality processes and procedures for data management activities.
*Attend regular data management meetings, as well as outlier calls and site initiation visits, as directed.
*Obtain professional training in relational databases or office software.
*Other clerical and administrative duties as assigned.
Communication:
Internal Interlocutors:
*Regular contact with all data management team members to obtain information required for the creation of databases and case report forms. Interacting with project managers in a tactful, professional manner is necessary to maintain business relationships.
External Interlocutors:
None
YOUR PROFILE
Knowledge:
Profile:
*A Bachelor's degree in a science related field
*At least three (3) years of data management or related work experience.
Required skills:
*Ability to work with complex, computerized records systems.
*Sophisticated knowledge of computer security and integrity.
*Working knowledge of good clinical practices, clinical research, clinical trial process and related regulatory requirements and terminology.
*Working knowledge of clinical database applications such as EDC and CTMS.
*Excellent verbal and... For full info follow application link.
Equal Opportunity Employer of Minorities, Females, Protected Veterans, and Individual with Disabilities
