Clinical Study Manager / Regional Lead

London, England, United Kingdom

1/20/2025

ABOUT US

At Quell we seek to deliver truly innovative, life-changing therapies for our patients. Our vision as a company is to build a major global biopharmaceutical company bringing transformational and valued therapies for a range of autoimmune and inflammatory diseases, as well as preventing rejection in organ transplantation, based on modular engineered Tregs.

OUR COMPANY

Quell Therapeutics Ltd ("Quell"), the world leader in the development of engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system, announced it has raised $156 million in oversubscribed Series B financing. The financing round was co-led by Jeito Capital, Ridgeback Capital Investments, SV Health Investors and Fidelity Management & Research Company LLC with participation from founding investor Syncona. New investors include British Patient Capital through its Future Fund: Breakthrough program, Janus Henderson Investors, Monashee Investment Management, Point72 and funds managed by Tekla Capital Management LLC.

THE ROLE

The Clinical Study Manager (CSM) is responsible for the management of clinical studies by collaborating with cross functional stakeholders and CROs/vendors to ensure each study is managed as per project plans, timelines and budget. The CSM will have regional oversight and play a pivotal role in engaging KOL and clinical sites to drive recruitment and retention. This position will report to the Associate Director / Director of Clinical Operations.

KEY RESPONSIBILITIES

As part of the Clinical Study Team, will drive effective decision making and ensure Sponsor oversight of the assigned studies from study planning, start up, conduct, and close-out.

Develop and execute strategy for site engagement to drive recruitment and retention.

Develop / maintain project plans and defining operational guidelines for each study.

Contribute to clinical protocols development

Ensure right-to-operate documents implementation in due times (e.g. Protocol, ICF, IB, DSUR)

Act as the main point of contact for the CRO and vendors.

Organise and manage internal team meetings, study-specific meetings, and meetings with sponsors/vendors/partners as applicable. Oversee the quality and scientific integrity of clinical operations for studies at a global level.

Maintain oversight of CRO-held eTMFs and Sponsor Oversight Folder.

Develop / maintain and execute clinical monitoring oversight strategy

Identify critical project success factors including probability, impact of potential project risks and respective mitigations.

Establishes project metrics and project report schedules. Develop, track, and report study specific KPIs for each study.

Manages adherence to project contracts and assists in the identification and development of scope change documents.

Lead or Support process improvement and compliance including leading cross functional initiatives, authorship /review of SOPs.

Support tracking of the financial spend, accrual and forecasts for appointed vendors on study.

Monitors project status, budget expenditures, and identifies problems, and recommend solutions.

Coordinates assignment of needed resources for project conduct and completion with functional area leaders.

Willingness to travel as needed (<20%) to support site engagement when permitted by company policy.

Other duties may be assigned as required.

Experience Requirements

• 2+ years' work experience as Clinical Project Manager/ Clinical Study Manager/ Clinical Trial Manager or equivalent gained in a biotech, pharmaceutical or CRO company.
• Experience and knowledge of managing ATIMP projects across multiple countries and time zones.
• Experience in oversight of external vendors (e.g. CROs, central labs, logistics vendors, etc.).
• Experience of working internationally, collaborating, and leading cross-functional teams in a fast-paced team environment.
  
  

Technical Requirements

• Knowledge of Guidelines and Regulations for ATIMP.
• Strong vendor management skills.
• Experienced in project management methodology and tools (e.g. MS Project etc)
• Excellent organisational, interpersonal and communication skills.
• Anticipate risks and problem resolution oriented with a "can-do" attitude.
• Excellent team working and networking skills with experience of interacting effectively across interfaces of discipline, culture, and expertise.
• Desire to work with integrity and act as an ambassador for Quell and the wider business.
  
  
  
  

Educational Requirements

• Batchelor's or Master's degree in Life Sciences
  
  
  
  

BENEFITS

• Holidays: 25 days per year
• Life Assurance: 4 x base salary
• Group Personal Pension: Auto enrolled at 6% employer contribution, 3% employee contribution
• Private Medical Insurance for your whole family
• Health Cash Plan
• Annual Bonus
  
  

PERKS

• Fantastic collaborative environment at Translation & Innovation Hub - Click here for Virtual Tour
• £61 Million Investment including brand new lab equipment, innovative methods, and exposure to cutting edge technology
• Flexible working
• Fast paced and progressive company looking for future leaders and innovators