The posting
Work with us Our team are passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and Autoimmune disease to deliver life-changing treatments to patients.
Whilst working at Autolus you will enjoy a flexible, diverse and dynamic working environment which actively promotes creativity, leadership and teamwork – together we are ONE Autolus.
Job Description:
Key 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, but not limited to, eCRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival; ensures deliverables are on time and within budget
· 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. This position will collaborate with key clinical trial delivery functions to define and implement data management requirements.
· 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.
· Establishes conventions and quality expectations for clinical data
· Establishes expectations for dataset content and structure
· Sets timeline and follow-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 (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency; ensures compliance with regulatory guidelines and the documentation matrix
· Provides input to the Clinical Study Lead (CPM) on trial initiation needs (scope of work, budget, resources), and vendor selection in non-standard situations as appropriate
· Identifies and communicates lessons learned, best practices and frequently asked questions at 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
- Participate in the development, review and implementation of policies, SOPs and associated documents affecting Data Management
- Identifies and participates in process, system, and tool improvement initiatives within Autolus
Demonstrated skills and competencies
E – Essential
P – Preferred
Experience
- 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)
- undefined
- 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)
Qualifications
- Degree-level qualification (E)
Skills/Specialist knowledge
- Provides oversight and management of external data management vendor(s).
- undefined
- Data Management/Project Management skills - demonstrates understanding and quality delivery of study/data management milestones according to established timelines
- Ability to handle complex projects and experience of early oncology clinical development
- Knowledge of cross functional roles and responsibilities
- Demonstrate strong problem solving and judgement skills
- Demonstrate professional communication skills - strong 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
Autolus is committed to the protection of the personal information that we collect & process and we are fully compliant with General Data Protection Regulations (GDPR).
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.
Autolus’ success is driven by equality and inclusion; we believe all voices are of equal value and must be heard. Whilst operating with focus and integrity, we are committed to improving diversity and inclusion within our business and our industry.
