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  • 4 weeks ago

jobs description

Job Description

Join Thermo Fisher Scientific and be part of meaningful work with a global impact. Our mission is to help our customers create a healthier, cleaner, and safer world. We empower our teams to reach their career goals while advancing science through research and delivering life-changing therapies. With clinical trials spanning over 100 countries and innovative approaches to clinical research, we focus on laboratory, digital, and decentralized trial services. Your commitment to quality and precision will enhance health outcomes for individuals and communities now and in the future.

Summarized Purpose:

Coordinate all aspects of clinical monitoring and site management. Conduct visits to ensure protocol and regulatory compliance, manage documentation, and collaborate with different sponsors and supervisory environments. Specialize in site processes to guarantee compliance with protocols and guidelines, ensuring subject rights, well-being, and data reliability. Develop... relationships with investigational sites and maintain audit readiness.

Key Responsibilities
• Monitor investigator sites using a risk-based approach, applying analytical skills to identify and address process failures. Ensure data accuracy through various monitoring activities. Document observations and escalate issues promptly for resolution. Maintain communication with investigative sites to ensure protocol adherence and data recording. Participate in the investigator payment process and collaborate on issue resolution.
• Provide trial status reports to the Clinical Team Manager and update study systems accordingly. Perform quality checks on generated reports as needed.
• Attend investigator meetings and identify potential investigators. Initiate clinical trial sites, ensure compliance, and manage trial closeout.
• Ensure all required documents are in place according to regulations. Assist in project tasks and share ideas with team members. Facilitate communication between sites, clients, and project teams.
• Respond to regulatory requirements, audits, and inspections. Complete administrative tasks accurately and in a timely manner.
• Contribute to project initiatives for process improvement.

Keys to Success

Education and Experience:

Hold a Bachelor's degree in life sciences or a relevant field. Previous experience equivalent to 2+ years in clinical research monitoring.

Knowledge, Skills and Abilities:
• Demonstrate effective clinical monitoring skills and understanding of medical terminology.
• Apply ICH GCPs, regulations, and procedural documents effectively.
• Show critical thinking abilities and manage Risk Based Monitoring processes.
• Communicate clearly and maintain customer focus. Possess strong organizational and time management skills.
• Work well in a team or independently. Demonstrate digital literacy and proficiency in Microsoft Office.
• Preference for monitoring experience in Slovenia or Bosnian citizenship living in Croatia.

Benefits

Enjoy competitive compensation, annual incentives, healthcare, and employee benefits. Thermo Fisher Scientific offers a dynamic work environment with excellent career development opportunities. Our company values integrity, intensity, involvement, and innovation, fostering a culture of collaboration and growth
Zagreb Croatia

salary-criteria

Apply - CRA (Level II) Zagreb