Study Start Up Lead – Sponsor dedicated

About This Opportunity

Our talent team is representing a confidential clinical research organization seeking a Study Start Up Lead for a sponsor-dedicated role. This position is home-based in the United States and offers the chance to drive global study start-up activities that directly impact patient access to innovative treatments.

In this role, you will plan and execute study start-up operations across multiple countries, leading cross-functional teams to ensure timely document preparation, regulatory submissions, and site activation. You'll work at the intersection of strategy and execution, collaborating with operational leads, vendors, and country managers to meet ambitious trial timelines.

Responsibilities

• Contribute study start-up insights to operational execution planning and configure trial-specific systems for global deployment
• Lead the study start-up team from kick-off through completion, ensuring all global templates, documents, and regulatory submissions are ready for country-level execution
• Oversee global vendor activation and coordinate with grants experts to finalize investigator budgets, fair market value assessments, and contract templates aligned with protocol timelines
• Implement protocol and operational plan amendments globally and oversee country-level implementation to maintain study integrity
• Provide proactive risk management and oversight of study start-up activities, proposing and implementing corrective actions to achieve quality execution within planned timelines
• Enable and support country study start-up managers in driving timely activities from country allocation through "Ready to Enroll" status
• Ensure global deliverables are in place for site initiation readiness and initial drug release, coordinating with vendors and country teams to meet activation plans
• Oversee global and country budget processes to support study start-up activities and timelines

What We're Looking For

• Bachelor's degree in life sciences or related field required
• 6+ years of clinical research experience, including at least 3 years in a leadership capacity on a global scale
• Demonstrated vendor management experience in a clinical trial environment
• Strong knowledge of the drug development process and regulatory requirements
• Excellent regulatory and technical writing skills with attention to detail
• High learning agility with proven problem-solving, influencing, and negotiation capabilities
• Ability to lead cross-functional teams and manage complex, multi-country study start-up timelines
• Experience with eTMF systems and study start-up tools preferred

How We Work With You

Candidates apply directly through the Get A Job.ai platform. Our recruiting team will conduct an initial screening to understand your background and career goals. If there's a strong match, we'll submit your profile to our client for consideration. Please do not contact the client directly, as all communication and coordination will be managed through Get A Job.ai to ensure a professional and streamlined process.

Pay

Compensation details will be discussed during the screening process based on your experience and qualifications.

Equal Employment Opportunity: Get A Job.ai is committed to inclusive hiring practices. We welcome applications from all qualified candidates regardless of race, color, religion, sex, national origin, age, disability, veteran status, or any other legally protected characteristic.