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About the Role
Autolus is passionate about advancing cancer therapy and autoimmune disease treatments. We offer a flexible, diverse, and dynamic work environment that fosters creativity, leadership, and teamwork to deliver life-changing treatments to patients.
Responsibilities
- Accountable for project management, oversight, and timely delivery of clinical trial data and documentation according to industry standards, timelines, budget, and quality requirements.
- Plans and tracks content, format, quality, and timing of data management deliverables, ensuring they are on time and within budget.
- Acts as the main liaison between the clinical study team, vendor, and other functional partners for data-related issues in CAR T clinical trials.
- Plans and manages data management aspects of global clinical trials through outsourced staff.
- Responsible for inspection readiness of all data management deliverables and ensures appropriate filing of documentation in the eTMF.
- Maintains oversight of outsourcing supplier contracts.
- Creates and reports data management updates to management, including performance to plan.
- Ensures clean and valid clinical study data for delivery and analysis.
- Collaborates with key clinical trial delivery functions to define and implement data management requirements.
- As a functional lead, ensures timely study start-up and database availability.
- Facilitates data cleaning and manages timeline to database lock, interacting with study sites as needed.
- Determines strategic direction for Electronic Case Report Form (eCRF) standards across external vendors.
- Reviews and approves applicable sections of regulatory submissions and contributes to regulatory submission strategy.
- Establishes conventions and quality expectations for clinical data.
- Establishes expectations for dataset content and structure.
- Sets timelines and follows up regularly to ensure delivery of all Data Management milestones.
- Performs trial level oversight controls as described in the clinical trial plan, QC process, and work instructions.
- Prepares or reviews clinical data management documents, ensuring compliance with regulatory guidelines.
- Provides input to the Clinical Study Lead on trial initiation needs and vendor selection.
- Identifies and communicates lessons learned, best practices, and frequently asked questions at the trial level.
- Identifies and participates in process, system, and tool improvement initiatives within Autolus.
- Presents and trains at site initiations, investigator, and monitor meetings.
- Participates in or leads non-trial/non-program projects based on specific expertise.
- Participates in the development, review, and implementation of policies, SOPs, and associated documents affecting Data Management.
Requirements
- Proven experience working with a Pharmaceutical/CRO/Biotechnology organization as a Clinical Data Manager.
- Minimum of 5 years of relevant professional experience in an industry-sponsored clinical trials environment.
- Experience in both CRO and sponsor data management positions is preferred.
Skills
- Oversight and management of external data management vendor(s).
- Data Management/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 judgment skills.
- Professional communication skills (oral and written English).
- Advanced knowledge and application of industry standards and best practices in clinical data management and applicable country regulations (US FDA, ISO, ICH, CDISC, ADaM, SAS).
- Haematological-Oncology, Autoimmune, or Neuroscience knowledge.
- Understanding of cell and gene therapy is a plus.
Location
- Remote
Work Type
- Full-time
Experience Level
- 5+ years relevant professional experience
Education Level
- Degree-level qualification in a scientific discipline
About the Company
- Autolus is committed to the protection of personal information and is compliant with General Data Protection Regulations (GDPR).
- Autolus' success is driven by equality and inclusion; we believe all voices are of equal value and must be heard.
- We are committed to improving diversity and inclusion within our business and our industry.
Equal Opportunity
- Autolus is committed to providing an inclusive and fair workplace for all.
- We are an equal opportunity employer and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic.
- We also provide reasonable accommodations throughout the recruitment process.