Jocelyn Blackham is recruiting for a Clinical Trial Manager to join an exciting organization moving into the clinical stage for their work in the autoimmune disease, oncology, neuro-inflation and several other disease models.

Clinical Trial Manager role:

- Providing trial management support for our cancer immunotherapy programs

- Preparation of study related materials, enrollment tracking and reporting to clinical development leadership

Relationship management between study sites and vendors (in particular CROs), supervision of study related activities

Key duties will include:

- Primary operational contact for execution of the study in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/Work Instructions

- Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders

- Operational input into study documents such as synopsis, protocol, Informed Consent Forms, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, etc.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

- Bachelor’s degree, or equivalent, in a biomedical, life science or related field of study

- Previous experience working within Clinical Operations experience within the Pharma, Biotech or CRO industry

- Previous experience working within Oncology/Immuno-oncology or immunology/inflammation is essential

- Good understanding of US regulatory and compliance requirements for clinical research

- Ability and willingness to travel up to 15% of time

For more information or to apply for this position, please contact Jocelyn Blackham on 617 2099 007 or email jblackham@ckscience.com. Please could you send any correspondence in English.