Job Title

CK Group are recruiting for a Clinical Project Manager, to join a growing early-stage Biotechnology company based near Manchester on a permanent basis. This is fantastic opportunity for an experienced Project Manager with a proven life science background in managing Phase I/II trials. The Role: This is a key operational role, where you will be responsible for driving our clients oncology programme from final GLP tox through to a first-in-human Phase I trial. You will be main point of contact and take ownership for coordinating CROs, stakeholders, vendors, and regulators to drive this exciting project to clinic. Responsibilities : Project leadership - build and maintain the integrated project plan for GLP tox, CMC, regulatory and clinical work-streams. Compile and submit CTA/IND, ethics track RFIs, manage agency correspondence (MHRA, FDA, EMA). Vendor & CRO management Support protocol development, investigator brochure, site selection Stakeholder engagement and management Your Background: Degree qualified/ PhD (preferred) with working knowledge on oncology, liposomes or gene therapy Proven and successful Project Manager with wealth of experience coordinating or managing Phase I/II trials (CRO, biotech or NHS R&D) Experience with CTA or IND submission and tracking Familiar with GxP, ICH, and MHRA processes. Apply : It is essential that applicants hold entitlement to work in the UK. Please quote job reference 161 053 in all correspondence. If this position isn''t suitable but you are looking for a new role, or if you are interested in seeing what opportunities are out there, head over to our LinkedIn page (cka-group) and follow us to see our latest jobs and company news.55b20050-bc17-4e5d-bfce-3c406318dffc