Study Start-up Lead

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.