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Job Details


Senior Manager of Data Management
Princeton, NJ  Posted: 5/20/2020

Details:

A Pharmaceutical Company has a need for a Sr. Manager of Data Management! Permanent position with Excellent Benefits!

Job Summary:  Responsible for ensuring data completeness and accuracy across multiple clinical studies from study start-up through database lock.   Identify and mitigate risks through collaboration with project study team.  Provide oversight of data management vendors to ensure project deliverables are completed on time and with quality.  
Duties & Responsibilities: 
• Provide day to day oversight of clinical data management vendors from database development through database lock
• Provides leadership and data management content expertise 
• Serve as primary point of contact to the wider study team for trial data related matters
• Coordinate CRF design with clinical team
• Participate in and lead User Acceptance Testing (UAT) through the creation and execution of test scripts and creation and entry of test data  
• Review and/or create data management documentation such as CRF completion guidelines, data management plan, data review plan, edit check specifications, data transfer agreements, etc.
• Identify project risks as they relate to collection and reporting of clinical study data
• Develop data management working instructions (WIs) and guidelines
• Lead and manage collection and reporting of clinical study data
• Review data for completeness and consistency
• Query data inconsistencies
• Report data management metrics 
• Perform SAE reconciliation 
• Interface with clinical project teams and lead meetings 
• Provide support and guidance to junior level data managers
• Support department and company initiatives
• Ability to travel (no more than annual average of 10%)
List of qualifications:
• Bachelor’s degree in related field
• At least 5 years’ experience as a data manager in a pharmaceutical company or CRO, with phase II/III FDA studies, or relevant clinical research experience
• Conducted all data management activities at all study stages - CRF design, edit check configuration, user acceptance testing, report generation, data cleaning, query generation, final data cleanup, database lock and study closure
• Understanding of database and dictionary structures (e.g. MedDRA, WHODrug)
• Authored data management plans and relevant WIs/SOPs
• Clinical experience an advantage
• Works independently
• Proactive, knows to move processes forward 
• Efficient, with good time management ability 
• Adherence to required study timelines
• Detail oriented and organized 
• Excellent inter-relationship skills
• Excellent technical skills

Job ID#:

7585

 



 

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