• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Assoc. Dir., Clinical Data Management

Job Number: 35050

Location:

Job Description

Reporting to the VP of Biometrics, the Associate Director of Clinical Data Management will lead data management processes for clinical trials, from planning to database lock. Responsibilities include initiating best practices, overseeing process flow, managing data vendors, and handling data transfers.

Responsibilities

  • Manage clinical data partnerships with CROs, overseeing outsourced activities from RFP to database lock
  • Develop and standardize data handling plans, transfer specifications, metrics, and review tools
  • Create database design, edit checks, CRF guidelines, and Data Management Plans, ensuring CDASH and SDTM standards
  • Collaborate with cross-functional teams for data collection and reporting
  • Work with internal and external partners to meet project timelines and budgets
  • Attend study team meetings to provide updates and resolve issues
  • Support eCRF library and database build configuration
  • Perform additional duties as needed

Required Skills

  • Bachelor’s degree in computer science or a science-based field
  • 8+ years of clinical data management experience in industry, with experience across indications and EDC platforms
  • 3+ years of management experience in a clinical research environment, preferably in various therapeutic areas including oncology
  • Strong vendor management and oversight skills
  • Solid technical skills across data platforms; programming experience preferred
  • Experienced in designing clinical trials using CDASH and SDTM standards
  • Proficient in collaborating with Biostatistics, Statistical Programming, and Pharmacovigilance
  • Knowledge of FDA and ICH GCP guidelines for clinical trial data reporting
  • Experience in regulatory GCP inspections/audits preferred
  • Familiarity with Spotfire, eluminate, or other data visualization software
  • Ability to manage multiple projects in a fast-paced environment

 

Apply for job

To apply for this job please visit k7y.pl.