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Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. 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.
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Active participation in Incident Management (IM) and Root Cause Analysis (RCA) for Problem Management activities. Extensive SME knowledge of network engineering and operations, integration, test and evaluation activities, as well as implementation and transition to Network Operations processes and concepts.
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Support the activities of the Maintenance Planner/Scheduler to ensure all BOM’s and PM are updated, required PMs are completed as scheduled and plant backlog is properly managed. Fluent with Root Cause Analysis (RCA), Failure Mode Effects Analysis (FMEA), and Problem Solving methods.
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Our global Clinical Operations colleagues within our PPD clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts.
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If you are a Nurse, Pharmacist, Site Coordinator, or you have other life science/pharma/CRO experience then please apply now to start your CRA career journey at one of the worlds leading global CROs! 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.
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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.
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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. This opportunity is available in Madrid, Barcelona, Andalucia and Galicia.
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Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
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Comprehensive experience as a clinician in a healthcare environment (comparable to at least 3 years) that provides transferable knowledge, skills, and abilities to perform the job in a clinical research environment.
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StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Expertise in a therapeutic area including, but not exclusive to oncology, medical surgery, pulmonology, or critical care (comparable to at least 2 years.
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For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.
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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.
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Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems. Good English language and grammar skills and proficient Spanish language skills.
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May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System.
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Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
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