Clinical Data Manager

Location
08648, Lawrence Township
Posted
Jan 05, 2021
Ref
34679
Discipline
Clinical
Required Education
Bachelors Degree
Position Type
Contract

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.

Our client, a leading Pharmaceutical company is hiring a Clinical Data Manager on a contracting basis.

Work Location: Princeton NJ

Summary:

  • Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects
  • Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects
  • Responsible for end to end clinical data management activities and serves as a primary point of contact for internal and external study team members
  • Provides strong quality and project oversight over third party vendor responsible for data management deliverables
  • Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway)
  • Enforces data standard conventions and quality expectations for clinical data per defined processes
  • Authors, reviews/revises DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization
  • Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency , quality and completeness
  • Represents DM on cross-functional project teams & submission Teams
  • Lead or support the Health Authority inspections and audits
  • Provides coaching and quality oversight of junior Data Management Leads
  • May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)


Required skills:

  • Project management certification (e.g. PMP) is desirable
  • Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
  • Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management
  • Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection
  • Strong project management; Exhibits expertise in metrics analysis and reporting methodologies
  • Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)]

 

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