Senior Clinical Data Manager (Biotechnology)

Location: Onsite in Dunkirk, New York, United States; Monday–Friday during standard business hours, with flexibility subject to manager approval.

Annual base pay: $117,900–$131,000, plus potential discretionary bonus and equity award.

Company

hirify.global is a publicly traded biotechnology company developing immunotherapies, cell therapies, cancer vaccines, and treatments for infectious diseases.

What you will do

• Create and review study-specific electronic and paper Case Report Forms.
• Configure, migrate, test, and manage EDC clinical trial databases, including edit checks and vendor deliverables.
• Develop data management plans, CRF completion guidelines, coding guidelines, annotated CRFs, and edit check specifications.
• Review clinical data, generate and close queries, and code adverse events and concomitant medications.
• Attend study meetings, prepare status reports and metrics, and advise clinical teams on data management strategies.
• Train investigators, study coordinators, internal colleagues, and junior staff in clinical data management processes.

Requirements

• Bachelor’s degree in a science-related field with 5+ years of experience, or a high school diploma with 9+ years of relevant experience.
• 5+ years of clinical data management experience.
• Experience working with EDC clinical databases.
• Working knowledge of clinical research, Good Clinical Practice, regulatory requirements, and CDISC/STDM standards.
• Excellent verbal and written communication, organizational, and interpersonal skills.
• Ability to work onsite in Dunkirk, New York.

Nice to have

• Experience with Veeva Vault CDMS and TrialMaster.
• MedDRA and WHO Drug coding experience.

Culture & Benefits

• Collaborative environment with opportunities to work across different areas of the company.
• Professional development opportunities in a growing biotechnology company.
• Medical, dental, and vision plan options, plus health and financial wellness programs.
• 401(k) retirement plan with company match and flexible spending accounts.
• Paid time off, holidays, disability coverage, life insurance, and additional employee assistance and discount programs.