Senior Clinical Data Lead – Hybrid: Data Integrity & Trials

Regulatory Jobs; Boston (MA); Hybrid; USD 145.000 - 217.000; Vollzeit

Zusammenfassung

Tango Therapeutics is seeking a Senior Manager, Clinical Data Management to lead data management activities across assigned trials, ensuring high-quality, inspection-ready data and sponsor oversight of CROs and external vendors.

The role covers data management planning, EDC/IRT/eCOA system build and validation, data cleaning, medical coding, and submission readiness, collaborating with cross-functional teams to support regulatory compliance and clinical development goals.

Qualifikationen

• Bachelor's degree in Computer Science, Life Sciences, Mathematics, Health Sciences, or related field.
• 5+ years of Clinical Data Management experience within biotech, pharma, or CRO.
• Experience with ICH-GCP and FDA/EU regulations.
• Experience leading data management for regulated trials.
• Familiarity with EDC, IRT, eCOA configurations and vendors.
• Strong data quality metrics and inspection readiness.

Aufgaben

• Oversee data management activities across the clinical trial lifecycle.
• Provide sponsor oversight of CROs and data vendors, including DM, IRT and eCOA.
• Ensure inspection-ready data through EDM, EDC, IRT, and eCOA oversight.
• Review and approve DM deliverables (CRF/eCRF, IRT, eCOA specs, edit checks, DMPs).
• Establish data quality KPIs and oversee data integration, transfer, and reconciliation.
• Lead audits/inspections readiness and assist regulatory submissions as needed.

Kenntnisse

Data governance

Vendor management

EDC systems

Clinical data management

Regulatory compliance

UAT

Data integrity

Cross-functional collaboration

Ausbildung

Bachelor's degree in related field

Tools

EDC platforms

IRT/eCOA systems

CDISC (CDASH/SDTM)

Data management tools

Jobbeschreibung

Tango Therapeutics is seeking a Senior Manager, Clinical Data Management to lead data management activities across assigned trials, ensuring high-quality, inspection-ready data and sponsor oversight of CROs and external vendors.

The role covers data management planning, EDC/IRT/eCOA system build and validation, data cleaning, medical coding, and submission readiness, collaborating with cross-functional teams to support regulatory compliance and clinical development goals.