Clinical Project Manager

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

• 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.

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.

INDCP