Work Schedule
Other

Environmental Conditions
Office

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

• Performs and coordinates all aspects of the clinical monitoring and site management process.
• Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation.
• Manages procedures and guidelines from different sponsors and/or monitoring environments.
• Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability.
• Ensures audit readiness.
• Develops collaborative relationships with investigational sites.

• Monitors investigator sites, applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
• Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
• Documents observations in reports and letters in a timely manner using approved business writing standards.
• Brings up observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
• Responds to company, client and applicable regulatory requirements/audits/inspections.

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
• Demonstrated understanding of ICH-GCP, EU and FDA requirements
• Experience of independent, on-site monitoring experience in a Pharmaceutical or Clinical Research Organisation

• Medical/therapeutic area knowledge and understanding of medical terminology
• Well-developed critical thinking skills, strong attention to detail
• Effective organizational and time management skills
• Ability to work in a team or independently as required
• Fluency in English language