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Senior Manager, Centralized Monitoring

1 month, 2 weeks ago
Anywhere
Full-time
Senior
Program Manager
Project and Program Management
GCP
Apply Now
Dianthus Therapeutics

Dianthus Therapeutics

Dianthus Therapeutics is focused on developing advanced complement antibody therapeutics, specifically engineered to provide targeted treatment for patients with significant unmet medical needs, exemplified by their lead product, claseprubart (DNTH103)...

Pharmaceuticals
11-50
Founded 2019
View All Jobs 6

Description

  • Lead and manage clinical data review activities across assigned studies.
  • Participate in data review and protocol deviation review meetings.
  • Collaborate with CROs to oversee data cleaning, query resolution, and database lock processes.
  • Review clinical data, listings, and reports to identify inconsistencies, trends, and potential issues.
  • Identify, assess, and escalate data anomalies and protocol deviations.
  • Partner with Clinical Development Operations, Clinical Development, Data Management, and Biostatistics to ensure data quality and compliance.
  • Develop and implement data review plans and contribute to data management plans.
  • Support data management activities, including CRF design and user acceptance testing.
  • Participate in CRO oversight, including performance monitoring and issue resolution.
  • Support audit readiness and regulatory inspections through strong data traceability and documentation.
  • Mentor junior team members and contribute to process improvement initiatives.

Requirements

  • Minimum of 5 years of experience in clinical research, including experience as a Sr. Clinical Research Associate, Lead CRA, or in a data oversight role.
  • Registered Nurse (RN) or equivalent clinical/medical background such as MD, PA, or study coordinator preferred.
  • Strong understanding of clinical trial processes, GCP, and global regulatory requirements.
  • Experience working with CROs and managing outsourced data review activities.
  • Proficiency in reviewing EDC systems and clinical data listings.
  • Experience with targeted source data verification (tSDV) is strongly preferred.
  • Excellent analytical, critical thinking, organizational, and communication skills.
  • Experience with process improvement initiatives such as process revision, plan development, or SOP development.
  • Ability to work independently in a fast-paced, startup environment.

Benefits

  • Remote work is available.
  • Opportunity to help build internal data review processes at a high-profile team.
  • Work on therapies for severe autoimmune diseases.
  • Contribute to regulatory submissions and scientific publications.

Interested in this position?

Apply directly on the company website

Apply Now

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