Local Study Associate Director

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

📋 Description

• Accountable at the national level for delivering the agreed components of clinical studies, adhering to allocated resources, budget, and timelines while complying with Client Procedural Documents, international guidelines like ICH-GCP, and pertinent local regulations.

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

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

• Ensures the timely creation of the country-level Master Informed Consent Form (MICF) and subsequent site-level ICFs, as necessary, including relevant translations, in accordance with client SOPs and local regulations.

• Oversees the timely submission of applications/documents to EC/IRB at the study's initiation and throughout its duration.

⛳️ Requirements

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

• Local experience with SSU oversight and end-to-end project involvement.

• Experience in oncology trials.

• Prior experience in site monitoring.

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

• Experience in submissions to Regulatory Authorities (RA) and Ethics Committees (EC).

• History of collaborating with study functions to ensure seamless delivery.

• Strong time management, organizational, interpersonal, and problem-solving skills, with the capacity to multitask and prioritize effectively.

• Solid understanding and practical knowledge of clinical research, phases of clinical trials, and current GCP/ICH guidelines along with local clinical research laws and regulations.

🏝️ Benefits

• Competitive salary.

• Attractive benefits package.

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

• Life Assurance coverage.

• Exceptional work environment.

• Culture emphasizing teamwork and collaboration.

• Access to innovative technology.

• Outstanding training opportunities.