Job Details
Our client is a leading organization in the antibody driven Immuno-oncology space with a proven platform that has garnered multiple hundred-million dollar industry partnerships to drive their 5+ clinical trials. This company has multiple wholly owned assets within Ph1 and Ph2 clinical studies and are looking for a Clinical Trial Manager/Sr. CTM to join their team to help manage and drive the success of these clinical assets.
Responsibilities:
- Oversee study execution to ensure compliance with regulatory standards (ICH/GCP) and internal procedures.
- Develop, manage, and update study timelines and plans through collaboration with 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
- Lead both an internal and external/CRO trial management team, to ensure the successful conduct of the trial in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs
Qualifications:
- Bachelor s degree, or equivalent, in a biomedical, life science or related field of study
- Minimum of 3 years of progressively increasing Clinical Operations experience within the Pharma, Biotech or CRO industry; Oncology/Immuno-oncology or immunology/inflammation experience required
- Good understanding of US regulatory and compliance requirements for clinical research
- Strong preference to a candidate with sponsor experience and familiar with in-house clinical management