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Data Manager - NJ in Berkeley Heights, NJ at Apex Life Sciences

Date Posted: 11/27/2018

Job Snapshot

Job Description

Responsibilities will include, but are not limited to: 1. Manage outside CROs and consultants: * Perform QC of CRO activities to include Query management, Data review, DM documentation such as edit checks, lock process * Monitor progress of data management activities by CROs * Participate in regular team meetings and provide input when appropriate

2. Other Activities: * Interact with CRAs, programmers, study managers and statisticians in creating an appropriate database, data quality assurance, and resolution of data queries * Regularly reconcile the Safety database to the EDC database

Skills/Knowledge Required: ***Must have relevant and extended experience. Must be able to work with minimal supervision. Must be able to communicate well. Must have experience in managing data management deliverables end to end. Project driven, not task driven.

*** * BS/BA degree or equivalent in a relevant scientific discipline with a minimum of three years experience as a data manager, or equivalent, in a pharmaceutical/CRO setting * THIS IS IMPORTANT ****Advanced knowledge of ***Excel**** and MS Visual Basic required * Knowledge of Medical Affairs helpful * Experience in Hematology and or Oncology *

Proficient knowledge of EDC databases, preferably Medidata RAVE. * Excellent communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers * Proficiency in regulatory guidelines, agencies, GCP * Knowledge of clinical trial process and data management process  


EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.