Senior Manager – Data Management

Job not on LinkedIn

🔥 0 minutes ago

🌐 United States, United Kingdom – Remote

🇺🇸 United States – Remote 🇬🇧 United Kingdom – Remote

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

⏰ Full Time

🟠 Senior

📊 Data Scientist

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Autolus Therapeutics

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $350M Post-IPO Equity - Autolus on 2024-02

Healthcare • Consulting • Manufacturing

Autolus Therapeutics is a clinical-stage biotechnology company developing next-generation autologous CAR T cell therapies for cancer and autoimmune diseases. The company applies advanced cell programming, proprietary viral vectors, and semi-automated T cell manufacturing to engineer precision CAR T products, and is advancing a pipeline that includes programs for hematological malignancies, solid tumors, and autoimmune indications. Autolus emphasizes integrated development and commercialization efforts, clinical trials, and publication of its research.

📋 Description

• 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