Senior Manager, Centralized Monitoring

Dianthustherapeutics

Remote
Remote
Clinical trial data integrity
Central data review process
Cro data oversight
The Senior Manager, Centralized Monitoring will play a critical role in ensuring the integrity, accuracy, and completeness of clinical trial data

Job Summary

  • The Senior Manager, Centralized Monitoring will play a critical role in ensuring the integrity, accuracy, and completeness of clinical trial data.
  • You will support bringing the central data review process in-house from the CRO, oversee data review activities across multiple studies, work closely with CRO Clinical Study Teams, and internal cross-functional teams to ensure high-quality data that supports regulatory submissions and scientific publications.
  • This is an exciting opportunity to be a part of a high profile team building our internal data review processes to ensure alignment across the development teams.

Matching Summary

The Senior Manager, Centralized Monitoring will play a critical role in ensuring the integrity, accuracy, and completeness of clinical trial data.

Skills & Requirements

Must-have

  • clinical trial data integrity
  • central data review process
  • CRO data oversight
  • protocol deviation review
  • GCP and regulatory requirements

Nice-to-have

  • startup environment experience
  • process improvement initiatives
  • elevate patient care culture

Key Requirements

  • Minimum of 5 years of experience in clinical research
  • Experience as a Sr. CRA, Lead CRA, or in a data oversight role
  • Registered Nurse (RN), or equivalent clinical/medical background preferred
  • Proficiency in reviewing EDC systems and clinical data listings
  • Experience with targeted source data verification (tSDV) strongly preferred

Work Rights

Not specified

Tailored Resume

Cover Letter