Senior Clinical Data Manager – CAR-T Trials

Autolus Inc; New Jersey; Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Private medical insurance

Life assurance

Pension

Job summary

Autolus Inc. seeks a seasoned Clinical Data Manager to oversee data management deliverables across global CAR T trials. You will coordinate with clinical teams, CROs and vendors to ensure data quality, timelines and regulatory readiness for inspections and submissions.

The role requires a strong background in eCRF, CDISC, and GxP, with 5+ years in clinical data management within biotech or pharma. A collaborative, cross-functional approach will be essential to drive data standards and trial

Qualifications

• Degree in a scientific discipline with proven experience in Pharmaceutical/CRO/Biotechnology.
• Minimum 5 years of relevant professional experience in industry-sponsored clinical trials.
• Experience in CRO and sponsor data management positions.
• Advanced knowledge of industry standards and country regulations (FDA, ISO, ICH, CDISC, ADaM, SAS).
• Haematological-Oncology, Autoimmune, or Neuroscience knowledge desirable.

Responsibilities

• Plan and manage data management deliverables and timelines for global trials.
• Liaise between the clinical study team, vendor and partners on data issues.
• Ensure data management readiness for inspections and eTMF filing.
• Oversee outsourced data management contractors and vendor relationships.
• Prepare data management documents and submission packages.
• Lead data standards development for eCRF and external vendors.

Skills

Data management

Project management

Regulatory knowledge

Communication skills

Problem solving

English proficiency

Education

Bachelor's degree in a scientific discipline

Tools

SAS

CDISC

eTMF systems

Job description

Autolus Inc. seeks a seasoned Clinical Data Manager to oversee data management deliverables across global CAR T trials. You will coordinate with clinical teams, CROs and vendors to ensure data quality, timelines and regulatory readiness for inspections and submissions.

The role requires a strong background in eCRF, CDISC, and GxP, with 5+ years in clinical data management within biotech or pharma. A collaborative, cross-functional approach will be essential to drive data standards and trial