This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.

Environmental Conditions Office At Thermo Fisher

Scientific, you'll discover meaningful work that makes a positive impact on a general scale. 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 different 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.

FSO, FSP, Government, etc.). 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.

This is a home-based position and preferably based in Western/Southern Australia Monitors investigator sites with a risk-based monitoring approach: 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. Assess investigational product through physical inventory and records review.

Documents observations in reports and letters in a timely manner using approved business writing standards. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts supervising tasks in accordance with the approved monitoring plan.

Ensures a shared responsibility with other project team members on issues/findings resolution. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.

Conducts on-site file reviews as per project specifications.

Clinical Trial Management

System). Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.



Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. Contributes to other project work and initiatives for process improvement, as required. Bachelor's degree in a life sciences related fielder a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) Proven clinical monitoring skills. Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving Ability to manage Risk Based Monitoring concepts and processes.

Good digital literacy: solid knowledge of Microsoft Office and the ability to learn appropriate software. Good English language and grammar skills. Australian citizenship or permanent residency required Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.

Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave. Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.

📌 Clinical Research Associate/Senior Clinical Research Associate (Málaga)
🏢 Thermo Fisher Scientific
📍 Málaga