Remote Study Start-Up Lead (Clinical Trials)

Ladders; United States; Remote; USD 100,000 - 120,000; Full time

Benefits offered by this job

Health coverage

Retirement plan

Life assurance

Disability coverage

EAP & wellbeing resources

Training & career development

Job summary

Ladders is seeking a Study Start-up Lead to oversee country-level activities for clinical trials in a remote US-based role. You will collaborate with CRAs, the Local Study Team, regulators and sites to keep milestones on track, from planning through activation.

The role requires strong project management and regulatory coordination, with the ability to manage multiple workstreams in a fast-paced environment. Competitive compensation is offered.

Qualifications

• 5+ years of clinical research experience with emphasis on study start-up.
• Bachelor's degree in life sciences preferred.
• Strong project management skills with regulatory expertise.
• Excellent written and verbal communication skills.
• Ability to manage tight deadlines and multiple priorities.

Responsibilities

• Manage country-level study start-up activities.
• Prepare, review, and track regulatory documentation for sites.
• Collaborate with CRAs and Local Study Team to meet milestones.
• Perform clinical and operational feasibility assessments to high standards.
• Ensure timely submissions to Regulatory Authorities.
• Participate in Local Study Team meetings.
• Update CTMS and manage data entry from study sites.
• Follow up on outstanding site actions to promote timely resolutions.
• Ensure compliance with ICH-GCP and client SOPs.

Skills

Project management

Regulatory coordination

Communication

Time management

Clinical research

Education

Bachelor's degree in life sciences

Tools

CTMS

Regulatory documentation tools

Job description

Ladders is seeking a Study Start-up Lead to oversee country-level activities for clinical trials in a remote US-based role. You will collaborate with CRAs, the Local Study Team, regulators and sites to keep milestones on track, from planning through activation.

The role requires strong project management and regulatory coordination, with the ability to manage multiple workstreams in a fast-paced environment. Competitive compensation is offered.