Clinical Project Manager

About Skye Bioscience

Skye Bioscience, Inc. is focused on unlocking the pharmaceutical potential of the endocannabinoid system to treat diseases with metabolic, inflammatory, and fibrotic processes. Backed by leading life science venture investors, Skye's strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with significant clinical and commercial differentiation. Nimacimab, a negative allosteric modulating antibody that inhibits peripheral CB1, showed a favorable safety and tolerability profile in a Phase 1 study. Skye plans to start a Phase 2 clinical trial in obesity comparing monotherapy and combination arms of nimacimab and a GLP-1R agonist in mid-2024. SBI-100 Ophthalmic Emulsion, a CB1 agonist, is currently being studied in a Phase 2 clinical trial of patients with glaucoma and ocular hypertension, with interim data expected in Q1 2024.  

Skye Bioscience is also a welcoming community of passionate biotech enthusiasts who aren't afraid to voice their opinions. The mission of the team is to enhance lives globally through innovative medicines. They don't claim to have all the answers, but they relentlessly pursue solutions. They invite like-minded, entrepreneurial individuals who resonate with their mission to consider joining them and contribute to their efforts. 

About the Role: 

The Clinical Project Manager is accountable for the daily operational oversight of one or more clinical trials from start-up, conduct, and close-out activities in accordance with the protocol, study plans, company SOP, GCP and other applicable regulatory requirements. The individual must be able to work independently and thrives in a fast-paced environment.

Responsibilities:

• Supports the conduct and execution of clinical trials in accordance with SOPs, GCP and relevant regulations. Communicates company expectations to selected vendors.

• Monitors progress of clinical activities, providing internal communication on the status on trial health, including metrics, deliverables, and budgeting.

• Assist in CRO/vendor feasibility, selection process and provides oversight of deliverables, timelines, and trial execution of selected vendor.

• Develop clinical trial documents including ICF templates, trial procedure manuals and trial training materials.

• Participates in the development and finalization of study protocols, study execution plans and core regulatory documents.

• Responsible for setting up project team meetings, distributing agendas, recording, and finalizing meeting minutes, and collating various presentations.

• Responsible for the set-up, maintenance, and QC of CRO managed TMF. Performs periodic reviews for accuracy and completeness.

• Proactively identifies potential study issues/risks, determines impact, and works to implement appropriate mitigation.

• Oversee data entry timelines, query management and metric reporting. Performs periodic …