Clinical Study Start-Up Manager (Onsite NJ)

eikontherapeutics; Jersey City (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Eikon Therapeutics is seeking an experienced Manager, Study Start Up to optimize clinical trial initiation across phases. You will partner with Senior Director, Study Start Up and clinical teams to drive feasibility, planning, and data-driven decisions to accelerate trials.

This onsite role requires at least 3 days per week in Jersey City, NJ, and focuses on start-up efficiency, site activation, and regulatory compliance under ICH/GCP guidelines, with a collaborative, detail-oriented approach.

Qualifications

• Post Graduate degree with 4+ years of experience or a Bachelor's degree with 6+ years in life sciences, healthcare, or related discipline.
• Solid understanding of US and global regulations and guidelines (FDA, EMEA, ICH) applicable to clinical development.
• Significant experience within the pharmaceutical industry or CRO with clinical data and development processes.
• Deep understanding of complexities of study start up.
• Strong analytical and project management skills.

Responsibilities

• Enhance analytics with Clinical Development R&D to ensure the right questions are asked and data is leveraged to drive feasibility and accelerate trials.
• Engage and develop strong working relationships with clinical study teams to generate the best outcomes for start up activities.
• Drive adherence to standards for planning and execution of study start up and country requirements, coordinating with Clinical Operations on site information management.
• Partner with Clinical Operations to ensure real-time collection of information for country allocation, investigator site identification through activation, forecasting and planning.
• Support Clinical Operations in successful execution of trials from protocol concept to Site Activation, complying with ICH/GCP/EMEA guidelines and SOPs.

Skills

Analytical skills

Project management

Clinical operations

US FDA knowledge

Cross-functional collaboration

Education

Bachelor's degree

Postgraduate degree

Job description

Eikon Therapeutics is seeking an experienced Manager, Study Start Up to optimize clinical trial initiation across phases. You will partner with Senior Director, Study Start Up and clinical teams to drive feasibility, planning, and data-driven decisions to accelerate trials.

This onsite role requires at least 3 days per week in Jersey City, NJ, and focuses on start-up efficiency, site activation, and regulatory compliance under ICH/GCP guidelines, with a collaborative, detail-oriented approach.