Job Details

  • Title: Sr. Data Manager
  • Code: RCI-9770
  • Location: Berkeley Heights New Jersey (NJ) 07922
  • Posted Date: 09/28/2020
  • Duration: 12 Months
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  Job Description

This role, DM Lead, will be responsible for overseeing both in-house and outsourced clinical trials. The DM Lead will collaborate heavily with the CRO DM and the study teams to ensure DM activities provide continuous data currency with accuracy and to meet deliverables without delay. The DM Lead needs to make sound decisions in collaboration with the study team and work toward agreeable resolutions. Also provides guidance on processes as needed ensuring the CRO DM is executing activities as expected. The DM Lead is a key functional area study team member for assigned clinical trials keeping the internal team appraised of study activities, rate limiting issues and escalations as appropriate. Responsibilities will include (not all inclusive)

 

Functional proficiencies:

  • Reviews synopsis/protocol and attends Synopsis Review Committee (SRC) meetings
  • Leads DM study start-up and maintenance activities - CRF design/edit check specifications/external vendor specifications, CRF completion guidelines, (CCGs), coding, IVRS, etc.
  • Leads development of site/investigator training materials and present at Investigator Meetings
  • Leads client team with User Acceptance Testing as applicable
  • Leads SAE reconciliation
  • Demonstrates ability to analyze data, share trends/observations with team members around results and relevant metrics
  • Leads data review and query management
  • Prepares the Data Management Plan and essential documentation
  • Adheres to data standards and proper data validation processes
  • Performs reconciliation of external data
  • Leads database lock activities: inclusive of final SAE reconciliation/final data review, study decommission, etc.
  • Lead/Participate in regular team meetings and provide input when appropriate
  • Core study team member and primary contact for data management
  • Provide input and assist in review/adherence to project timelines

CRO/vendor oversight:

  • Provides oversight of vendor activities to ensure quality and timely deliverables
  • Participates in CRO/external vendor selection
  • Review Statement of Work (SOW)/contracts
  • Provides CRO oversight of the data management functional activities and monitor progress and deliverables
  • Ensures training on client SOPs, if applicable

Other Activities:

  • Proficient in writing function SOPs/Working Practices;
  • Interpersonal skills - Interact with study team to create an appropriate database per protocol design with data integrity checks;
  • Assist in database upgrades/migrations including performing User Acceptance Tests

Skills/Knowledge Required:

  • BS/BA degree or equivalent in a relevant scientific discipline or a minimum 3-5 years of experience as a Lead Data Manager in a pharmaceutical/CRO setting;
  • Proficient knowledge of EDC RAVE databases;
  • Excellent communication skills;
  • Ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers etc.
  • Knowledgeable in regulatory guidelines, agencies, GCP;
  • Advanced knowledge of clinical trial process and data management process