Study Start Up Lead

This is a fully remote position, open to applicants in Poland.

📋 Description

• Lead and manage study start-up activities for assigned projects from the moment of award until site activation.

• Create and uphold start-up plans, timelines, and project milestones.

• Collaborate with Project Managers to identify potential risks and execute mitigation strategies.

• Oversee submissions to the Ethics Committee (EC/IRB) and work in tandem with Regulatory teams on Health Authority requirements.

• Assist with site feasibility, site activation, and greenlight processes.

• Facilitate the negotiation of clinical trial agreements in partnership with Legal and operational teams.

• Ensure that all study documentation is thorough, precise, and filed with the Trial Master File.

• Track start-up metrics and provide consistent progress updates to project stakeholders.

• Promote continuous improvement initiatives, develop SOPs, and implement operational best practices.

• Participate in bid defenses, proposals, and business development efforts as needed.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Nursing, or a related discipline.

• At least 4 years of clinical research experience, primarily focused on study start-up activities.

• Strong comprehension of ICH-GCP guidelines and regulatory standards.

• Proven experience in coordinating multiple projects within a fast-paced environment.

• Exceptional organizational, planning, and problem-solving capabilities.

• Outstanding written and verbal communication skills in English.

• Familiarity with submissions in the US and Australia is a plus.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional development.

• A collaborative and innovative work environment.