Senior Manager – Data Management

Autolus Therapeutics

. Manage project oversight and timely delivery of clinical trial data and documentation according to industry data standards, timelines, budget, and quality requirements .

Posted 10/21/2026full-timeRemote • New Jersey • United States, United KingdomSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Clinical Data Management, ensuring compliance with industry standards and regulatory requirements while managing complex clinical trials. Proven ability to oversee external vendors and maintain data integrity throughout the clinical trial process.

Highest-signal resume keywords

Clinical Data ManagementProject ManagementRegulatory ComplianceVendor OversightOncology Clinical Development

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

ECRF ManagementData Review PlanQuality Control PlanDatabase Lock ManagementClinical Trial OversightData CleaningSubmission Package PreparationSOP DevelopmentStatistical Analysis System (SAS)Clinical Trial Documentation

Soft Skills

Problem-SolvingJudgment SkillsOral CommunicationWritten CommunicationTraining and Presentation Skills

Tools & Technologies

ETMFData Management SystemsClinical Trial Management Systems (CTMS)Regulatory Submission ToolsProject Tracking Tools

Industry Keywords

PharmaceuticalCROBiotechnologyHaematological-OncologyAutoimmuneNeuroscienceCell and Gene TherapyUS FDAISOICH

About the role

Key responsibilities & impact

Manage project oversight and timely delivery of clinical trial data and documentation according to industry data standards, timelines, budget, and quality requirements
Plan and track clinical data management deliverables, including eCRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan, and archival
Serve as the main liaison between clinical study teams, vendors, and functional partners on data-related issues for assigned CAR T clinical trials
Manage data management aspects of global clinical trials through oversight of outsourced data management staff
Maintain inspection readiness and ensure appropriate filing of data management documentation in the eTMF
Maintain oversight of outsourcing supplier contracts
Report data management updates and performance against plan to management
Ensure clean and valid clinical study data for clinical study teams and subsequent analysis
Serve as a functional lead on clinical study teams, ensuring timely study start-up and database availability
Facilitate data cleaning and manage timelines to database lock; interact with study sites and site management; own database lock
Determine strategic direction for eCRF standards across external vendors
Review and approve applicable regulatory submission sections and contribute to regulatory submission strategy
Establish conventions, quality expectations, dataset content, and structure for clinical data
Set timelines and follow up on Data Management milestones
Perform trial-level oversight controls according to clinical trial plans, QC processes, and work instructions
Prepare or review clinical data management documents and submission packages for quality, scientific content, clarity, accuracy, consistency, and regulatory compliance
Advise the Clinical Study Lead on trial initiation needs, scope, budget, resources, and vendor selection
Identify and communicate lessons learned, best practices, and frequently asked questions
Participate in process, system, and tool improvement initiatives
Present and provide training at site initiations, investigator meetings, and monitor meetings
Participate in or lead non-trial and non-program projects
Participate in developing, reviewing, and implementing Data Management policies, SOPs, and associated documents

Requirements

What you’ll need

Degree in a scientific discipline
Degree-level qualification
Proven experience working with a Pharmaceutical, CRO, or Biotechnology organisation as a Clinical Data Manager
Minimum 5 years of relevant professional experience in an industry-sponsored clinical trials environment
Experience providing oversight and management of external data management vendors
Data Management and Project Management skills
Ability to handle complex projects
Experience of early oncology clinical development
Knowledge of cross-functional roles and responsibilities
Strong problem-solving and judgement skills
Strong oral and written English
Advanced knowledge and application of industry standards and best practices in clinical data management
Knowledge of applicable country regulations and standards, including US FDA, ISO, ICH, CDISC, ADaM, and SAS
Haematological-Oncology, Autoimmune, or Neuroscience knowledge; understanding of cell and gene therapy is a plus
Experience in both CRO and sponsor data management positions is preferred

Benefits

Comp & perks

Flexible, diverse and dynamic working environment
Reasonable accommodations throughout the recruitment process
Inclusive and fair workplace
Equal opportunity employment