- MD, DO, RN, PharmD or similar with experience in Oncology clinical development
- Minimum of 3 years of experience, including 2 years as a medical monitor for clinical trials (Phase I – III)
- Good verbal and written communication skills essential
- Experience managing projects, coordinating activities and adhering to tight timelines
- Responsible for initial review and assessment of potential PV, SAE, and general clinical safety monitoring, provide workup for safety special issue workups, as required, all for final review by CMO.
- Responsible for primary medical review of EDC for all clinical studies with respect data verification, safety and efficacy parameters and presentation of data as required. Will enter and follow-up medical queries and liaise with CRO / CRAs and sites as necessary to optimize data accuracy and quality.
- Participate in the overall conduct and management of clinical studies through the clinical team, in conjunction with CMO, and other Medicenna clinical and operational staff and CRO’s.
- Conduct analyses and prepare summary reports, as agreed within the executive team, to support interim assessment of studies and evaluate potential course changes.
- In collaboration and agreement with CMO, interface with imaging CRO and radio-oncologists at clinical sites for review of all images and responses in conjunction with consultants and vendors. Manage conflict resolution and troubleshoot when necessary.
- Contribute to the preparation of clinical regulatory submissions, e.g. clinical sections of IB and study reports, in collaboration with clinical team members, vendors and CMO.
- Responsible for development of clinical and scientific protocol, and the preparation of protocol amendments, for final sign off with CMO.
- Support preparation of regulatory meetings and ongoing interactions with the various regulatory agencies / health authorities and other official bodies, according to plans agreed in the clinical team.
- Provide clinical evaluation and oversight of results from central labs. Troubleshoot where required with experts, sites and vendors.
- Provide oversight, evaluation, and management of clinical vendors / CROs, on behalf of (and in liaison with) the executive team.
- Take an active role in supporting patient recruitment, enrolment and retention. Assist CMO with clinical evaluations and site liaison as required.
- Participate in on-site and TC meetings with investigators and meet PI as required.
- Contribute to the development of a publication plan and the preparation of manuscripts and other publications (e.g. congress submissions) including completion of existing draft manuscripts.