The Fountain Group

Remote Manager Evidence Generation Data Management

New Jersey, US

Remote
$65–$70
1 day ago
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Summary

Details for the position are as follows:

  • 100% remote - must be okay working EST hours mainly.
  • 12-month contract to start with the possibility of extension or conversion depending on performance and budget.
  • Rate: $65 - 70 an hour

Job Description:

  • The position holder will manage, with direction, end-to-end delivery of data management services for assigned studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget.
  • The position holder will partner with internal and external stakeholders to optimize Data Management technology, processes, and standards.
  • The position will have a working knowledge of Electronic Data Capture/related applications and industry standards, and moderate technical skills in working with data received from CROs and other third-party vendors.
  • The position holder may act as a Biometrics Project Manager to plan and coordinate cross functional Evidence Generation execution of the study deliverables
  • Responsible, with supervision, for study activities assigned related to the Data Management study set up, conduct, and close out. Ensure timely, to budget and accurate completion of Data Management deliverables, including but not exclusive to the Data Management Plan
  • Database specifications, Database build, interim data cuts, Database lock and study archiving
  • Leads the data review process in collaboration with the study team to ensure data quality
  • Contribute, with supervision, to documents submitted to Regulatory or Pricing Authorities. Must comply with international regulations
  • Ensure inspection readiness as well as prepare potential audits linked to assigned studies
  • With supervision, responsible for routine oversight of vendor delivery , to ensure compliance with the protocol, external/internal standards applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.
  • Participates in drafting request for proposal for CRO selection. Reviews base-line budget and timelines. Contributes to budget management and activities across the project duration
  • Participate in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions
  • Maintains current knowledge of industry best practice in Data Management methodology, Data Integrity, and Data Privacy
  • Any other duties deemed pertinent to the needs of the business

Required Skills:

  • Must have 4 + years of professional pharmaceutical industry expertise or related healthcare experience (i.e., CRO) supporting end-to-end delivery of data management related to post marketed drug development.
  • Must have oncology data management experience
  • Must have expertise in late phase projects would be highly preferred

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