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About the Role

The Principal Clinical Project Manager is the strategic and operational leader of clinical trials, translating corporate strategy into executable plans while ensuring delivery of study milestones with optimal quality, timeline, and budget performance. This role is accountable for implementing quality by design principles from study conception through execution, leading cross-functional teams, and providing oversight of CRO/vendor partnerships. The Principal CPM drives proactive risk management and strategic decision-making to ensure successful study delivery. As a senior member of the Clinical Operations team, the Principal CPM supports program-level activities as delegated and provides mentorship to other members of the CPM team.

Responsibilities

Autonomously leads one or more complex / pivotal clinical studies, providing leadership, operational strategy and direction to cross-functional clinical study team members (in-house and outsourced) from concept to closeout
Supports Clinical Programme Lead (CPL) in developing operational strategies to optimally deliver study(ies) within the program
May assume delegated program-level responsibilities from CPL, including representation on Project Team Sub-teams / Working Groups and / or delivery oversight of a subset of studies within a programme
Acts as mentor / coach to other CPMs; May assume line management responsibilities of CPM / Clinical Project Associate (CPA) / Clinical Study Specialist (CSS) staff upon request
Supports optimization of Clinical Operations processes, including leading strategic initiatives and continuous improvement activities
Acts as Subject Matter Expert / Process Owner for assigned SOPs and processes
Accountable for managing overall study timelines, budgets, and quality targets, ensuring effective tracking and forecasting/reforecasting
Partners with Site Management and Engagement to jointly develop country/site selection, recruitment and patient engagement strategies for optimal study delivery
Partners with Product Delivery to ensure clinical supply planning meets study requirements
Leads cross-functional risk-based quality management approaches, ensuring appropriate risk identification and mitigation strategy development
Critically assesses safety and efficacy endpoints and ensures implementation of effective tools and training(s) to enable protocol and GCP compliance
Accountable for building, forecasting, and managing the Clinical Trial Budget
Manages study team communications to ensure effective decision-making and cross-functional connectivity among study team members and supporting functional lines
Develops study vendor strategy, participates in vendor selection and provides vendor management oversight for delivery and quality
Oversees protocol compliance, ensures protocol deviations are tracked/assessed, trends identified, and adjustments made to operations and/or protocol
Reviews and approves monitoring visit reports, identifying and addressing reported issues/trends
Drives inspection readiness activities, providing oversight of electronic Trial Master File (eTMF) to maintain inspection-ready status
Collaborates in Data Management Plan development; Inputs on CRF/eCRF design; Reviews edit check specifications; Inputs on data review strategy and collaborates with DM to monitor data quality metrics
Drives project management of data cleaning / database snapshots and locks
Develops study-specific training plan for the clinical study team members and ensures documentation of training in eTMF
Provides comprehensive operations input to protocol design
Maintain and enhance knowledge in Haem/Onc and/or Autoimmune
Develop and maintain project plans and documents following ICH-GCP and company SOPs
Responsible for adhering to all health and safety guidance provided by the Company

Requirements

15 years+ clinical research experience, including 10 years+ in clinical project management (or equivalent) roles
Experience in managing full-service out-sourced projects
Experience in hematology/oncology and/or autoimmune phase I/II studies
Experience with ATIMPs, site-level management and managing pivotal trials an advantage

Skills

Adept at working in a global setting and matrix environment
Broad experience in a Clinical Trial Execution discipline (e.g. senior study management expertise, data management experience, clinical leadership expertise)
Demonstrated project management/leadership experience
Experience in understanding of key drivers impacting budgets and managing project to budget
Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and service providers
Ability to manage in complex and challenging environments
Thorough knowledge of ICH-GCP guidelines and FDA regulations
Knowledge of medical terminology and clinical patient management
Ability to manage multiple projects
Excellent communication, interpersonal and organisational skills
Highly effective problem solving skills
Computer literacy, proficiency in Microsoft Office
Ability to work independently and to effectively prioritise tasks
Ability to travel internationally (20-30%)

Location

London

Work Type

Full time

Experience Level

15 years+ clinical research experience
10 years+ in clinical project management

Education Level

Relevant life science first degree (BSc or equivalent)
Higher degree an advantage MSc/PhD

Salary/Compensations

competitive salary
performance related bonus

Benefits

private medical insurance
life assurance
pension

About the Company

Autolus is a biopharmaceutical company, advancing innovative therapies at both clinical and commercial stages of development, focused on next-generation, programmed T cell therapies for the treatment of cancer.
Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled, and highly active T cell therapies designed to better recognize cancer cells, break down their defence mechanisms, and eliminate these cells.
Autolus has a pipeline of product candidates in development for the treatment of haematological malignancies, solid tumours, and autoimmune diseases.

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.
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.