Senior Manager/ Associate Director, Data Management

Autolus Therapeutics•London, NJ

19d

About The Position

The Senior Manager/ Associate Director, Data Management is accountable for project management, oversight, and timely delivery of clinical-trial data and documentation to industry standards and agreed timeline, budget, and quality requirements. The role manages data-management activities for global CAR T clinical trials, including oversight of outsourced staff and vendors, and serves as the main liaison for data-related matters among the clinical study team, vendors, and functional partners. The position leads data-management planning and delivery throughout the trial lifecycle, from study start-up and database availability through data cleaning, database lock, submission, and archival. It ensures data quality, inspection readiness, appropriate eTMF filing, and compliance with applicable regulatory guidelines. The role also contributes to submission strategy, defines clinical data conventions and standards, supports vendor and resource decisions, and participates in policies, process, system, and tool improvements. The successful candidate will have a degree-level qualification in a scientific discipline and relevant clinical data management experience in a pharmaceutical, CRO, or biotechnology organization. The position calls for strong data and project management capabilities, vendor oversight, knowledge of clinical-trial regulations and standards, and experience handling complex projects, including early oncology development.

Requirements

Degree-level qualification in a scientific discipline.
Proven experience working with a pharmaceutical, CRO, or biotechnology organization as a Clinical Data Manager.
At least 5 years of relevant professional experience in an industry-sponsored clinical-trial environment.
Experience providing oversight and management of external data-management vendors.
Data-management and project-management skills, including the ability to deliver study and data-management milestones to established timelines.
Ability to handle complex projects and experience in early oncology clinical development.
Knowledge of cross-functional roles and responsibilities.
Strong problem-solving and judgment skills.
Professional communication skills, including strong oral and written English.
Advanced knowledge and application of industry standards and best practices in clinical data management and applicable country regulations, including US FDA, ISO, ICH, CDISC, ADaM, and SAS.

Nice To Haves

Experience in both CRO and sponsor data-management positions.
Knowledge of haematological oncology, autoimmune disease, or neuroscience.
Understanding of cell and gene therapy.

Responsibilities

Manage and oversee clinical-trial data and documentation delivery to agreed standards, timelines, budgets, and quality requirements.
Plan and track data-management deliverables, including eCRFs, data review and QC plans, oversight plans, database release plans, final datasets, submission plans, and archival.
Serve as the primary liaison on data-related issues among the clinical study team, vendors, and functional partners for assigned CAR T clinical trials.
Plan and manage data-management aspects of global clinical trials through oversight of outsourced data-management staff.
Ensure inspection readiness and appropriate filing of data-management content and documentation in the eTMF.
Maintain oversight of outsourcing supplier contracts relevant to the role.
Provide regular management updates on data management and performance against plan.
Ensure clean and valid clinical study data are delivered to clinical study teams for analysis, collaborating with trial delivery functions to define and implement data-management requirements.
Lead data-management activities on clinical study teams to support timely study start-up and database availability.
Facilitate data cleaning, manage timelines to database lock, interact with study sites and site management as needed, and take responsibility for database lock.
Determine the strategic direction for eCRF standards across external vendors.
Review and approve applicable regulatory submission sections and contribute to clinical-program submission strategy.
Establish conventions and quality expectations for clinical data and expectations for dataset content and structure.
Set timelines and follow up regularly to ensure delivery of data-management milestones.
Perform trial-level oversight controls in accordance with the clinical trial plan, QC process, and work instructions.
Prepare or review clinical data-management documents, including submission packages, for quality, scientific content, organization, clarity, accuracy, format, consistency, and regulatory compliance.
Advise the Clinical Study Lead on trial initiation needs, including scope of work, budget, resources, and vendor selection in non-standard situations.
Identify and communicate trial-level lessons learned, best practices, and frequently asked questions.
Participate in process, system, and tool improvement initiatives within Autolus.
Present and provide training at site initiations, investigator meetings, and monitor meetings.
Participate in or lead non-trial and non-program projects based on specific expertise.
Participate in developing, reviewing, and implementing policies, SOPs, and associated documents affecting Data Management.