Clinical Project Manager (CPM)
Location: White City, London
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.
Quell was founded in March 2019 in partnership with six prominent immunological experts from King’s College London, University College London, and Hannover Medical School, and is led by Iain McGill, a leading pharmaceutical executive with extensive relevant experience, having spent most of his 25 years in the industry in immunology, including the areas of solid organ and cell transplantation. The Company was founded with initial series A financing, led by Syncona Ltd who committed £59M with a further £2M contributed by UCL Technology Fund.
Clinical Project Manager (CPM)
The Clinical Project Manager (CPM) is accountable for the global 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 CPM will play a pivotal role in leading the multifunctional study management team responsible for execution of Quell clinical studies. This position will report to the Director of Clinical Operations. Strong candidates will bring knowledge and experience in the fundamental aspects of trial and study site management, vendor management, and experience in the full cycle of study from start-up to close out.
The incumbent will adhere to Quell values and work in compliance with all applicable regulations, guidelines notably ICH-GCP guidelines and SOPs. Strong candidates will bring knowledge and experience in managing complex project involving ATIMP, strong vendor management associated with planning and risk management.
- Lead the Clinical Study Team to drive effective decision making and ensure Sponsor oversight of the assigned studies from study planning, start up, conduct, and close-out.
- Develop project plans and defining operational guidelines for each study.
- Act as the main point of contact for the CRO and vendors
- Organize 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.
- Design 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.
- 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.
- Other duties may be assigned as required.
- Willingness to travel as needed (<15%) to support the execution of clinical studies. Currently, all work-related travel is on hold. Travel will only be required once travel activities can safely resume.
EXPERIENCE WE ARE LOOKING FOR
- 4+ 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.
- Experience in immunology and solid organ transplant therapeutic area is a plus.
- Batchelor’s or Master’s degree in Life Sciences
TECHNICAL SKILLS REQUIRED
- Knowledge of Guidelines and Regulations for ATIMP
- Strong vendor management skills
- Experienced in project management methodology and tools (e.g. MS Project) and process map visualisation (e.g. Visio, Lucidchart).
- 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.
- Holidays: 25 days per year
- Life Assurance: 4 x base salary
- Group Personal Pension: Auto enrolled at 4% employer contribution, 4% employee contribution
- Private Medical Insurance for your whole family
- Annual Bonus
- 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