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

Date Posted: 7/12/2018

Job Snapshot

Job Description


Description:

  • As a senior level contractor, responsibilities will include, but are not limited to overseeing the management of clinical trial databases from study start up to study closure at CRO (or when required, support other DMs) by performing the following activities: 
    • Review and understand protocol synopsis and attend if required any protocol review meetings and act as subject matter expert for proper data capture based on protocol requirements. 
    • Lead Case Report Form Design according to the protocol with all Study Team members using established standards 
    • Author or review CRF completion guidelines 
    • Develop or lead in the review of a Data Management Plan (DMP), when applicable, that outlines database design and testing, CRF flow, data queries, manual checks, coding, SAE reconciliation, third party vendor reconciliations, specification of data listings needed to facilitate data cleaning in accordance to a Data Review Plan, data lock and archiving, etc. 
    • Develop and test edit specifications which may include the development of test scripts used for UAT as well as perform/coordinate UAT testing 
    • Ensure coding has been performed and reviewed by Medical Coder, 
    • Perform external data reconciliation, provide data management related metrics, provide specific data listings as required by the medical group and review when necessary 
    • Make data, including interim data, available to company personnel and to regulatory agencies when required 
    • Trouble-shoot database issues with DBA until resolution is obtained 
    • Perform database lock and freeze activities 
    • Prepare and present data collection requirements at Investigator Meeting 
    • Participate in CRO selection 
    • Review SOWs for data management activities and costs in contracts 
    • Participate in regular team meetings and provide input when appropriate 
  • Other Activities may include:
    • Interact with physicians, scientists, monitors, programmers, study managers and statisticians in creating an appropriate database, data quality assurance, and resolution of data queries 
    • Assist in database upgrades/migrations including performing User Acceptance Tests 
    • Serve as the DM representative on clinical project teams that are developing NDAs 

SKILLS/KNOWLEDGE Required: 

  • BS/BA degree or equivalent in a relevant scientific discipline with a minimum of 5 years of experience as a LEAD data manager in a pharmaceutical/CRO setting 
  • Experienced in understanding Sponsor responsibilities of oversight of a CRO. 
  • Immunology, Inflammatory and Clinical Pharmacology is highly desirable, 
  • Proficient knowledge of Medidata RAVE, Experience with RaveX is a plus 
  • Knowledge of of JReview is a plus. 
  • Basic knowledge of budget forecasting 
  • Proficiency in regulatory guidelines, agencies, GCP 
  • Advanced knowledge of clinical trial process and data management process 
  • Excellent communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers

To apply for this position please send resume or contact:

Vickie Dagit, Recruiter

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.