• Serve as The Lead on topics related to Clinical Data Management activities in a multifunctional team.Experience managing study start-up, conduct and lock as lead CDMBe accountable for CDM deliverables from protocol review to database closure and oversee production of SDTM datasetsExperience in translating clinical protocols into electronic case report forms and developing the associated edit check specificationsResponsible for contributing to vendor selection and management, assume operational and/or oversight responsibility as Lead Clinical Data Manager for outsourced studiesAbility to understand and develop specifications or Data Transfer Agreements with external vendors (e.g. IxRS, PK, Biomarker or Imaging groups)Coordinate data transfer activities from external vendorsAdhere to and develop Standards related to eCRFs, edit checks other packages related to CDM deliverablesPerform duties in compliance with SOPs and Good Clinical Practices (GCP) set by ICHKnowledge of data privacy and GDPR preferred

  • Project Management

  • Proven ability to run multiple concurrent studies while also participating in special projects or process improvement initiatives

  • Good project management skills and the use of PM tools (e.g. MS Project)

  • Ability to prioritize task, identify, and mitigate risks concerning timelines

Data Quality

  • Be able to produce or summarize and present database metrics (query status, missing data/pages etc.)

  • Understand the data flow process and be able to create reports from raw dataset, and be able to use reporting tools (e.g. MS excel, J-review, SAS or R)

  • Spearhead the review of protocol deviations with the study team to identify valid patients for analysis sets and, plan and conduct of interim and final blind table review meetings

  • Engage in ongoing data review/reconciliation activities or spot check vendors and utilize reports, metrics and patient trackers to monitor data quality

Documentation

  • Document all activities adequately for assigned studies according to Standard Operating Procedures (SOPs) by initiating, maintaining and archiving documents to be audit/inspection ready at all times

  • Be able to develop or review plans associated with the CDM function (i.e., Project Plan/Timelines, Data Management Plan, Operational Oversight Plan, etc.) to ensure proper governance of data management activities

Educational and Qualification Requirements

  • Minimum of Bachelors degree in natural or physical sciences, health or Informatics related

  • Preferred Master s degree in the above fields

  • At least 4 years of study level experience as a Data Manager in supportive and leading roles

  • Good understanding of the drug development process

  • Must have sufficient knowledge of clinical research operations in order to execute relevant data management activities independently

  • Strong organizational skills and able to collaborate with minimal supervision

  • Demonstrated understanding of regulations and guidelines (e.g. ICH, GCP Privacy rules [HIPPA, GDPR])

Preferences:

  • Basic SAS, R, SQL or other programming knowledge preferred

  • Experience in using database and database tools

  • Job Function: Database Management
  • Education Level: Bachelors Degree ( 16 years)
  • Work Remote: No
  • Travel: No

Associated topics: data analytic, data center, data warehousing, database, database administrator, etl, erp, mongo database, sql, sybase

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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