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

Date Posted: 3/22/2018

Job Snapshot

Job Description


Responsibilities will include, but are not limited to: 

  • Perform a Quality Check (QC) of all types of EDC database discrepancies/queries generated for a study to identify and report any data trends, database/programming errors, possible training issues, etc. 
  • Run/generate reports from EDC database for QC of queries 
  • Review and/or reference study protocols for understanding of procedures to be collected for the trial 
  • Review and/or reference data management documents such as Data Management Plan (DMP) and eCRF Completion Guidelines when applicable, to understand the established process and guidelines for Case Report Forms during review of the database queries. 
  • Reference and follow the applicable SOP/WP for the process 
  • Demonstrate ability to analyze data, share trends/observations with team members around results and relevant metrics 
  • Review/spot check data review listings/reports for any data trends or findings for a study 
  • May provide CRO oversight of the data management functional activities and monitor progress and deliverables for a study 
  • May lead DM study start-up and maintenance activities for a study 

Knowledge/Competencies Required: 

  • BA/BS in a relevant scientific discipline; minimum five years experience as a lead Data Manager in a pharmaceutical/CRO setting 
  • Plans and executes own area of responsibilities through predefined standards and objectives 
  • Work is completed under minimal supervision 
  • Shows solid interpersonal skills 
  • Ability to work on multiple studies/projects and manage workload 
  • Working knowledge of EDC databases, preferably Medidata RAVE. Knowledge of J-Review or other reporting tool and basic understanding of SDTM and CDISC 
  • Strong written and oral communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers 
  • Ability to work in a study team environment 
  • Intermediate knowledge of therapeutic area(s) 
  • Knowledge of FDA/ICH guidelines and industry standard practices regarding data management

To apply for this position please send resume or contact:

Vickie Dagit, Recrutier

vdagit@apexlifesciences.com

919-334-0178

#LI-VD1

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 employeeservices@apexsystemsinc.com or 844-463-6178.