Manager Clinical Study Lead

Location: Armonk, NY or Warren, NJ, United States; onsite expectations may apply. Up to 25% travel may be required.

Salary: $128,600–$210,000 annually

Company

hirify.global is a pharmaceutical company conducting global clinical research and development.

What you will do

• Lead cross-functional study teams and oversee clinical study execution against timelines, deliverables, quality requirements, and budgets.
• Provide operational input into protocols, conduct feasibility assessments, select regions and sites, and lead investigator meeting preparation.
• Oversee study documentation, trial management systems such as CTMS and TMF, clinical trial registrations, and related compliance activities.
• Manage CRO and vendor engagement, contracting, scope delivery, budget control, and change management.
• Lead risk assessment and mitigation, site activation, monitoring oversight, patient recruitment and retention strategies, and data query resolution.
• Manage study closeout, including database lock, vendor reconciliation, TMF and study drug accountability, clinical study report review, and lessons learned.

Requirements

• Bachelor’s degree and at least six years of relevant industry experience.
• Extensive budget management expertise and demonstrated vendor management experience.
• Experience building productive study teams and leading cross-functional collaborations.
• Strong proficiency with clinical 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 and study document development, and knowledge of ICH/GCP and relevant regulatory guidelines.
• Strong project management, organizational, and clinical study operational leadership skills.

Culture & Benefits

• Inclusive workplace and equal opportunity employment.
• Comprehensive rewards package that may include bonuses, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Background checks may be conducted where required by applicable law.