Clinical Operations Lead (Biopharmaceutical Clinical Research)

Location: Fully remote; position listed in Wilmington, Delaware, United States

Company

hirify.global is a global biopharmaceutical company developing proprietary therapeutics in Hematology, Oncology, Inflammation, and Autoimmunity.

What you will do

• Support Clinical Trial Managers and operational teams in executing clinical trials.
• Review, develop, and write study manuals, laboratory and biomarker plans, informed consent templates, and related trial documents.
• Coordinate and monitor investigative sites, review monitoring reports, and serve as an initial liaison for site questions and escalations.
• Manage study timelines, recruitment tools, patient retention plans, meetings, and key deliverables.
• Coordinate clinical trial materials and co-medication strategy, including quantities, labeling, depots, and tracking.
• Manage CROs and ancillary vendors while supporting data review, discrepancy resolution, and pharmacovigilance coordination.

Requirements

• BS/BA degree or another relevant degree with a strong emphasis on science.
• At least three years of biopharmaceutical industry or relevant clinical research experience.
• Working knowledge of ICH Good Clinical Practice and applicable regulatory and health authority requirements.
• Ability to manage multiple priorities across several protocols and therapeutic areas.
• Experience assisting with multinational clinical trials is preferred.

Culture & Benefits

• Fully remote work arrangement.
• Collaboration with multidisciplinary clinical trial teams and international investigative sites.
• Opportunity to contribute to efficiency, effectiveness, and quality improvements within Development Operations.
• Equal opportunity employer committed to a diverse work environment.