Senior Clinical Data Manager — UAT/SAE/EDC Lead (Relocation)

StatMinds LLC.

King of Prussia (PA)

On-site

USD 116,000 - 142,000

Full time

14 days+

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Benefits offered by this job

Medical Insurance
Dental Insurance
Vacation and sick Days
Relocation Allowance
Per Diem Option
Visa Sponsorship

Job summary

StatMinds LLC is seeking a lead data manager to create DM plans, review coding conventions, and supervise UAT on clinical data bases. The role includes leading programming for analysis datasets, TLFs, data validation, and study documentation maintenance.

The candidate will execute SAE and data reconciliation across several clinical trials and ensure QC/UAT of EDC tools, with travel to various locations in the US as needed.

Qualifications

  • Master’s degree in Health Care Informatics or Health Administration with 1 year of related experience.
  • Experience documenting DM documents in Veeva Vault eTMF and reviewing ALS, eCRF specifications, and aCRFs.

Responsibilities

  • Create a data management plan (DMP), edit check specs, data transfer agreements (DTS), and a reconciliation plan.
  • Perform UAT on Clinical Data Base and provide feedback on programmed listings and edit checks.
  • Lead programming for analysis datasets, Tables, Listings and Figures, and study documentation maintenance.
  • Execute SAE and data reconciliation for multiple clinical trials.
  • Ensure QC and UAT of EDC tools and modules, including database testing and data exporting.

Skills

SAE
UAT
Veeva Vault
EDC tools

Education

Master’s degree in Health Care Informatics or Health Administration

Tools

Veeva Vault
EDC tools

Job description

StatMinds LLC is seeking a lead data manager to create DM plans, review coding conventions, and supervise UAT on clinical data bases. The role includes leading programming for analysis datasets, TLFs, data validation, and study documentation maintenance.

The candidate will execute SAE and data reconciliation across several clinical trials and ensure QC/UAT of EDC tools, with travel to various locations in the US as needed.

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