Clinical Data Manager in Bedminster Township, NJ at Apex Life Sciences

Date Posted: 11/9/2018

Job Snapshot

Job Description


Apex Life Sciences is seeking a Clinical Data Manager to join a Research and Development Group (R&D) which is responsible for all FDA related research and supports all non-FDA company sponsored research. 

Responsibilities: 

  • Create and review (electronic) Case Report Forms per Protocol and annotated Case Report Forms 
  • Review Protocols to ensure database feasibility 
  • Develop/build, review, and maintain a clinical database and supporting specifications documentation 
  • Develop/build, document and perform validation of database structure, data capture screens, code lists, edit checks, reports and other functions in EDC (e.g. User Acceptance Testing) 
  • Develop data transfer agreements and specifications with various vendors 
  • Write, review and maintain eCRF completion guidelines, data management plan (DMP), data validation plan (DVP, e.g. edit checks), and other DM related documentation 
  • Perform all aspects of DM process as related to processing and QC of the data 
  • Clean data for study close out and perform all database lock procedures 
  • Manage reconciliation with any external data (e.g. SAE, lab) 
  • Monitor study status (e.g. enrollment, CRFs, etc.) and provide status reports to the team 
  • Use standard conventions, tools, references and process in support of the coding of medical terms 
  • Ensures all DM procedures executed with a high attention to detail, accuracy and timelines 
  • Represent the DM function on project teams 
  • Write and review DM SOPs in accordance with GCP and ICH guidelines, and develop associated training and competency testing 
  • Maintain CRFs m1d database standards 
  • Work in conjunction with Clinical Operations, Clinical Research, and other operations to ensure accurate, efficient, and complete data collection 
  • Mentor junior level staff on database management tasks and processes 
  • Contribute/participate in data management initiatives 
  • Other duties as assigned 

Requirements: 

  • B.S. in Mathematics/Statistics, Computer Science, Life Sciences or related field 
  • 8+ years of data management experience in the pharmaceutical or biotechnology industry 
  • Highly organized and detail-oriented with effective planning with strong verbal and written communication skills 
  • Flexibility mi1d agility to adapt to changing scope of work, able to propose thoughtful solutions to challenges and issues, proactively implement solutions, and communicate effectively with colleagues 
  • Experience/knowledge of GCP and ICH guidelines 
  • Proficient in Microsoft Office applications (PowerPoint, Microsoft Word, Microsoft Excel, etc.), Internet software, E-mail 
  • Proficient with Clinical Data Management Systems (CDMS) and experience with Electronic Data Capture (EDC) systems 
  • Experience with SAS (Base, Stats, Macro, etc.) 
  • Experience with CDISC SDTM/CDASH 
  • Experience with study database build (including edit check programming) 
  • Experience in software development, software implementation, testing and validation 

***For immediate consideration, please email your updated resume to ksavas@apexlifesciences.com with 'Clinical Data Manager NJ' in the subject line.

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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.




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