Study Start-up Lead

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

For our client, we are seeking a Study Start-up Lead to join the team of a leader in the Pharmaceuticals & Biotech space.
This role will oversee country-level study start-up activities and help ensure clinical trials progress efficiently from planning through site activation. The position requires close collaboration with CRAs, the Local Study Team, regulatory stakeholders, and study sites to keep start-up milestones on track. Success in this role will depend on strong project management, regulatory coordination, and the ability to keep multiple workstreams moving in a fast-paced research environment.
Location: Remote - US based candidates only, no visa sponsorship available
Compensation: $100,000 – $120,000 annually

Responsibilities

• Manage and conduct study start-up activities at the country level
• Prepare, review, and track regulatory documentation for sites
• Collaborate closely with CRAs and the Local Study Team to meet milestones
• Perform clinical and operational feasibility assessments to high standards
• Ensure application and document submissions to Regulatory Authorities are timely
• Participate actively 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 regarding essential documents

Qualifications

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

Benefits

• Comprehensive rewards package supporting health and wellbeing
• Health coverage including medical, dental, and vision
• Retirement and pension plans available
• Life assurance and disability coverage provided
• Access to employee assistance and wellbeing resources
• Structured training and career development opportunities

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.