Senior Manager – Data Management
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Job Description
Clinical data management leader overseeing outsourced vendors, database lock, and regulatory deliverables for Autolus CAR T trials. Supporting life-changing cancer and autoimmune therapies.
Responsibilities:
- 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:
- 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:
- Flexible, diverse and dynamic working environment
- Reasonable accommodations throughout the recruitment process
- Inclusive and fair workplace
- Equal opportunity employment
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