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 reviews of EDC data for trends, outliers, and potential risks.
Performs detailed monitoring oversight, ensuring compliance to the monitoring plan and suitability of monitoring strategies and assigned CRAs. Tracks monitoring visit intervals, report completion and report review. May train or re-educate CRAs as needed.
Serves as a site liaison, resource and point of escalation as needed in support of the site/CRO/vendor.
Provides input on the development of departmental SOPs and processes.
Provides support during regulatory inspections.
May provide administrative assistance on more than 1 trial.
Perform other duties as assigned.
Qualifications:
Demonstrates a positive, ‘can do’ and service-oriented attitude. Skilled in developing collaborative internal and external relationships.
Able to collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
Excellent interpersonal, written, and verbal communication skills, as position will interface with investigators, site staff and various team members across vendors and functional groups.
Self-motivated, dedicated to quality; detail-oriented with ability to shift priorities quickly under tight deadline.
Capable of providing oversight to CROs and other vendors.
Prior monitoring or co-monitoring industry experience and/or interested in learning co-monitoring and monitoring oversight
Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint) and web-based data platforms.
Experience
Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies.
Strong knowledge of data cleaning, site monitoring and management.
Industry clinical trial experience in phases II and III from start-up to close-out
3-5 years of industry clinical trial experience, including 1-2 years in clinical trial management and vendor oversight in biopharma or CRO setting.
BS or BA in a relevant scientific discipline, or equivalent combination of education and experience.
*Please note we are not using external recruiting agencies for this role*
United States only