Manager, Clinical Study Lead

Location: Armonk, NY or Warren, NJ, United States; 25% travel may be required.

Salary: $128,600–$210,000 annually.

Company

hirify.global is a biotechnology and pharmaceutical company developing medicines through clinical research and global trial operations.

What you will do

• Lead cross-functional teams delivering smaller or less complex global clinical trials from study design through closeout.
• Manage study timelines, budgets, deliverables, risks, quality, and scope changes for internal and outsourced studies.
• Provide operational input into protocols, feasibility assessments, site selection, investigator meetings, and recruitment and retention strategies.
• Oversee clinical trial documentation, study systems such as CTMS and TMF, registry compliance, data review, and query resolution.
• Lead CRO and vendor engagement, contracting, performance management, and oversight.
• Supervise Clinical Trial Management staff and contribute to process improvements and clinical study report development.

Requirements

• Bachelor’s degree and at least six years of relevant industry experience.
• Extensive budget management, vendor management, study team leadership, and collaboration experience.
• Strong proficiency with trial management systems and Microsoft Project, PowerPoint, Word, and Excel, as well as IVRS/IWRS and EDC platforms.
• Experience in global clinical trial operations, protocol development, and preparation of key study documents.
• Solid knowledge of ICH/GCP and relevant regulatory guidelines, with strong project management, organizational, and cross-functional leadership skills.
• Ability to implement operational strategy and guidance for clinical studies.

Culture & Benefits

• Onsite expectations may apply because many roles are performed together in the workplace.
• Benefits may include annual bonuses or incentive plans, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support.
• Reasonable accommodation is available during recruitment for applicants with disabilities or chronic illnesses where required.
• Background checks may verify identity, right to work, and educational qualifications in accordance with applicable law.