Clinical Data Management Lead - Oncology Trials

Remix Therapeutics; Watertown (MA); Vor Ort; USD 187.000 - 230.000; Vollzeit

Zusammenfassung

Remix Therapeutics, based in Watertown, MA, seeks an Associate Director of Clinical Data Management to lead data management activities for REM-422 and related programs. You will manage CROs, set governance, and ensure data quality across trials in oncology/rare disease indications.

Reporting to the SVP of Clinical Development Operations, you will drive CDISC/CDASH standardization, oversee budgets, and ensure readiness for regulatory submissions while guiding the DM team through IND to NDA

Qualifikationen

• BS/BA in a scientific, informatics, or healthcare discipline; advanced degree preferred.
• 8+ years in clinical drug development focused on Clinical Data Management.
• Deep expertise in EDC systems (Medidata Rave, Veeva Vault CDMS).
• Advanced knowledge of ICH-GCP, FDA/EMA guidelines, and CDISC standards.
• Proven track record managing full-service data management CROs and vendors.
• Oncology or rare disease trial experience preferred.
• Experience supporting programs from IND through NDA submissions and inspections.

Aufgaben

• Oversee DM CROs and vendors, ensuring deliverables meet quality standards.
• Establish KPIs, governance, and oversight meetings to track progress and resolve issues.
• Participate in CRO selection, RFPs, and budget management including SoW and change orders.
• Review and approve DMPs, eCRF designs, edit checks, UAT setups, and data transfer specs.
• Lead data management lifecycle from study start-up to archival and closure.
• Ensure data integrity through listings and data visualization, identifying risks.
• Ensure compliance with ICH-GCP and prepare for inspections; act as SME during audits.
• Collaborate on CDISC/CDASH standards for downstream submissions.

Kenntnisse

Leadership

Data management

Cross-functional collaboration

Analytical thinking

Ausbildung

BS/BA in a scientific/informatics/healthcare discipline

Master's or Ph.D. preferred

Tools

Medidata Rave

Veeva Vault CDMS

Jobbeschreibung

Remix Therapeutics, based in Watertown, MA, seeks an Associate Director of Clinical Data Management to lead data management activities for REM-422 and related programs. You will manage CROs, set governance, and ensure data quality across trials in oncology/rare disease indications.

Reporting to the SVP of Clinical Development Operations, you will drive CDISC/CDASH standardization, oversee budgets, and ensure readiness for regulatory submissions while guiding the DM team through IND to NDA