Hybrid Clinical Study Associate Manager - Global Trials

KPS Life; Warren (MA); Hybride; USD 110 000 - 150 000; Plein temps

Résumé du poste

KPS Life is seeking a Clinical Study Associate Manager (CSAM) dedicated to our sponsor partner. The role is hybrid, three days per week, in Armonk NY, Warren NJ, or Cambridge MA, supporting global clinical trial delivery from planning to closeout.

You will work with Clinical Study Leads, cross-functional teams, and CROs to ensure milestones, quality, and regulatory compliance. A minimum of four years' experience in clinical research is required.

Qualifications

• Bachelor's degree and at least 4 years of relevant experience.
• Knowledge of ICH-GCP and applicable regulatory guidelines.
• Proficiency with clinical trial systems (CTMS, EDC, IWRS/IVRS) and Microsoft Office tools.
• Strong attention to detail and the ability to manage study activities accurately.
• Excellent communication, presentation, interpersonal, and leadership skills.
• Proactive, self-disciplined, with strong time management and budgeting awareness.

Responsabilités

• Support regional study planning and management in alignment with global study plans.
• Contribute to feasibility assessments, risk evaluations, and mitigation strategies.
• Assist in site activation, monitoring visits, investigator meetings, and recruitment strategies.
• Provide study status updates to stakeholders and ensure deliverables meet timelines.
• Develop and review study documents and oversee CTMS and TMF-related activities.
• Support vendor engagement, contracting, and ongoing management.
• Assist with study budget management and forecasting, including drug accountability.

Connaissances

Attention to detail

Communication skills

Time management

Leadership

Cross-functional collaboration

Formation

Bachelor's degree

Outils

CTMS

EDC

IWRS/IVRS

Teams

Office

Project

Description du poste

KPS Life is seeking a Clinical Study Associate Manager (CSAM) dedicated to our sponsor partner. The role is hybrid, three days per week, in Armonk NY, Warren NJ, or Cambridge MA, supporting global clinical trial delivery from planning to closeout.

You will work with Clinical Study Leads, cross-functional teams, and CROs to ensure milestones, quality, and regulatory compliance. A minimum of four years' experience in clinical research is required.