Northreach | Clinical Study Manager - Cell Therapy

Northreach is a recruitment agency that connects businesses with top talent in the cell & gene therapy, fintech, and digital sectors. Our mission is to provide clients and candidates with a seamless and personalised recruitment experience and create a positive work environment that encourages equality, innovation, and professional growth.

My client is looking to find a sesoned Clinical Study Manager for it\’s Cell Therapy portfolio. This is a permanent role and will require the successful candidate to be onsite at their London offices 1 day per week. Applicants MUST have experience in Cell Therapy or ATMP products.

• 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 WE ARE LOOKING FOR

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 ATMP 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

Northreach is an equal opportunity employer and we do not discriminate against any employee or applicant for employment based on race, colour, religion, sex, national origin, disability, or age. We are committed to promoting diversity, equity, and inclusion in the workplace and hiring practices, therefore only partner with business that promote DEI. We strive to create a welcoming and inclusive environment for all employees.