Local Study Associate Director

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

📋 Description

• Accountable at the country level for delivering the agreed components of clinical studies within the specified resources, budget, and timelines, while adhering to Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations.

• Ensures the timely preparation of the country financial Study Management Agreement (fSMA) and maintains an accurate study budget in the client clinical studies financial system through regular system checks and financial reports.

• Directs and enhances the performance of the Local Study Team(s) at the country level, ensuring adherence to client Procedural Documents, ICH-GCP, and local regulations.

• Guarantees the timely preparation of the country-level Master Informed Consent Form (MICF) and subsequent site-level ICFs as required, including any necessary translations, in alignment with relevant client SOPs and local regulations.

• Ensures the timely submission of applications/documents to EC/IRB at the startup and throughout the study duration.

⛳️ Requirements

• A minimum of 5 years of trial management experience (as COL or CTM).

• Local experience, including SSU oversight, end-to-end experience, and oncology trial experience.

• Previous experience in site monitoring.

• Demonstrated ability to lead and inspire cross-functional teams to deliver clinical trials on or ahead of schedule, within budget, and with the required quality.

• Experience in submitting to RA and EC.

• Proven ability to collaborate with study functions to ensure seamless delivery.

• Strong time management, organizational, and interpersonal skills, along with problem-solving capabilities, enabling effective multitasking and prioritization.

• Solid understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH guidelines, and country-specific clinical research laws.

🏝️ Benefits

• Competitive salary.

• Attractive benefits package.

• Car or car allowance.

• Comprehensive medical care plan: Health, Dental & Vision.

• Life Assurance.

• Excellent work environment.

• Culture of teamwork and collaboration.

• Supportive colleagues who tackle challenges together.

• Access to innovative technology.

• Exceptional training opportunities.