Clinical Project Manager

Hobson Prior are looking for a Clinical Project Manager to join a leading biotechnology organisation on a permanent basis. This is a fantastic opportunity to join an organisation that is developing the next generation of life-changing immunotherapies for patient with cancer.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• You will be responsible for developing and/or contributing to the development of project specific procedures, manuals and instructions.
• Participate in preparation, tracking and forecasting of milestones and project budgets.
• Responsible for efficient implementation, execution and reporting of assigned clinical projects in accordance with protocol, timelines, and approved budget.
• Review of protocols and other essential documents (e.g. CTR, IB, DSUR).
• Manage the preparation and update of project plans, key documents or tools (e.g. ICF, eCRF, eTMF).
• Coordinate logistics of project materials and ensure timely provision to sites (e.g. IMP, laboratory kits).
• Coordinate feasibility study, site selection and initiation process.
• Ensure appropriate training of involved CRO personnel and the consistent use of project specific tools and procedures.
• Manage the efficient operational day-to-day activities of clinical projects and ensure protocol and ICH-GCP compliance.
• Supervise CRO/vendor performance.
• Define, track and report metrics (e.g. schedules, milestones, critical path) to provide continual visibility of status and deliverables.
• Identify and manage potential recruitment or operational issues - assist in problem resolution efforts such as protocol amendments.
• Identify quality issues early and escalate findings and develop/implement corrective action plans in close alignment with Quality Assurance.
• Ensure through efficient site management that data is entered into eCRF according to visit schedule.
• In close alignment with Data Management supervise the complete data management process.
• Supervise setting, maintenance and regular quality control of the eTMF.

Requirements:

• The ideal candidate will require a master's degree or PhD in a scientific or health-related field.
• A minimum of 5 years' CPM experience with leading global oncology trials (phase I-III) and multi-functional teams.
• Strong organisational and communication skills.
• Demonstrated leadership and project management skills - experience in managing CROs is a benefit.
• Extensive operational clinical trial management knowledge including startup, maintenance & close out.
• Advanced understanding of GCPs and ICH guidelines.
• Fluency in English (verbal and written).

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.