Senior Data Management Lead - Clinical Trials

Autolus Therapeutics; United States; Remote; USD 110,000 - 170,000; Full time

Job summary

Autolus Therapeutics in the United States is seeking an experienced Clinical Data Manager to lead data management activities for CAR T clinical trials. You will oversee data deliverables, manage timelines and budgets, coordinate with study teams and external vendors, and ensure inspection readiness of eCRF and datasets.

The role requires a degree in a scientific discipline, at least five years in industry trials, and familiarity with CDISC, ICH, FDA guidelines.

Qualifications

• The successful candidate should hold a degree in a scientific discipline with proven experience of working with a Pharmaceutical/CRO/Biotechnology organisation, as Clinical Data Manager (E)
• At minimum of 5 years of relevant professional experience in industry sponsored clinical trials environment (E)
• Ideally worked in both CRO and sponsor data management positions (P)

Responsibilities

• Accountable for the project management, oversight and timely delivery of clinical trial data and documentation to relevant industry data standards and according to agreed timelines, budget and quality requirements
• Plans and tracks content, format, quality, and timing of data management deliverables, including eCRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival
• Act as the main liaison between the clinical study team, the vendor and other functional partners for all issues related to data for assigned CAR T clinical trials
• Plan and manage data management aspects of global clinical trials through management and oversight of outsourced data management staff
• Responsible for Inspection Readiness of all data management deliverables and ensures appropriate filing of data management documentation/content to the eTMF for inspection readiness/compliance
• Responsible for maintaining oversight on outsourcing supplier contracts in line with the role
• Create and report data management updates to management on a regular basis; report on performance to plan
• Ensures clean and valid clinical study data for delivery to clinical study teams and subsequent analysis
• As a functional lead on the clinical study team, ensures timely study start up and database availability
• Facilitate data cleaning and manage timeline to database lock; interact with study sites and site management as needed; responsible for database lock
• Determine strategic direction for Electronic Case Report Form (eCRF) standards across external vendor
• Review and approve applicable sections of regulatory submissions and contribute to regulatory submission strategy for clinical programmes

Skills

Data management

Project management

Regulatory knowledge

Communication

Vendor oversight

Education

Science degree

Tools

eCRF systems

Job description

Autolus Therapeutics in the United States is seeking an experienced Clinical Data Manager to lead data management activities for CAR T clinical trials. You will oversee data deliverables, manage timelines and budgets, coordinate with study teams and external vendors, and ensure inspection readiness of eCRF and datasets.

The role requires a degree in a scientific discipline, at least five years in industry trials, and familiarity with CDISC, ICH, FDA guidelines.