Senior Data Manager — Clinical Trial Data Lead

vorbiopharma; Boston (MA); In loco; USD 110.000 - 165.000; Tempo pieno

Descrizione del lavoro

Vor is seeking a Senior Data Manager to lead data management activities from start-up through database lock, ensuring accuracy and consistency while meeting regulatory standards. The role includes mentoring, process improvement, and cross-functional collaboration to deliver high-quality data for multiple studies.

You will oversee internal teams and external vendors, drive quality, and maintain documentation and timelines to support efficient clinical development and timely submissions.

Competenze

• Bachelor's Degree in computer sciences, health-related sciences, or relevant field; 7+ years DM experience.
• Hands-on experience with data management tasks and DM vendor oversight.
• Extensive experience with clinical data management within industry-sponsored trials.

Mansioni

• Serve as data lead for one or more clinical trials with full data management ownership.
• Drive quality and efficiency to meet timelines in collaboration with cross-functional study teams.
• Oversee data management activities by CROs and third-party vendors to meet obligations.
• Be the first DM point of contact to ensure milestones and deliverables are met with high quality.
• Ensure alignment with data management expectations for the assigned compound/indication.
• Review DM documentation (CRF design, DMP, Data Transfer Specifications).
• Oversee edit check specifications to support data collection and analysis per protocol.
• Ensure the clinical database adheres to CDISC SDTM standards and guides data collection.
• Contribute to clinical development plans and potential innovative trial designs.
• Set milestones and timelines for DM deliverables and ensure readiness for inspections.

Conoscenze

Data management

Project coordination

Quality control

SOP adherence

Formazione

Bachelor's degree in computer sciences/health-related sciences

Strumenti

Clinical data management systems

Descrizione del lavoro

Vor is seeking a Senior Data Manager to lead data management activities from start-up through database lock, ensuring accuracy and consistency while meeting regulatory standards. The role includes mentoring, process improvement, and cross-functional collaboration to deliver high-quality data for multiple studies.

You will oversee internal teams and external vendors, drive quality, and maintain documentation and timelines to support efficient clinical development and timely submissions.