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Using this data-driven approach, PPD can address study problems or site performance quickly, directing remediation activities where needed and positioning on-site monitoring activity in a targeted approach.
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PPD's centralized monitoring group delivers a new approach to risk surveillance and centralized statistical monitoring, combining the power of statistical and analytical tools with expertise from operationally experienced staff to monitor and manage clinical study data.
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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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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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Entes and maintains trial status information relating to SIA activities onto PPD. Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and. and maintained as per PPD WPDs or applicable client SOPs.
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StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System.
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Sites and study are aligned to the critical path for site activation. Ensures the local country study files and filing processes are prepared, set up. May work with the start-up CRA(s) to prepare the regulatory compliance review.
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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! Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
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Therapy approvals, viral safety dossiers, import license) in alignment with global. Bachelor's degree or equivalent and relevant formal academic / vocational qualification. Provides, under guidance local regulatory strategy advice (MoH &/or EC) to.
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Mutually agreed upon timelines; ensures alignment of submission process for. Prepares, reviews and coordinates, under guidance, local regulatory submissions. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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PPD values the health and wellbeing of our employees. At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We are the people of PPD thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health.
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Key-contact at country level for either Ethical or Regulatory submission-related. May assist with grant budgets(s) and payment schedules negotiations with sites. Provides project specific local SSU services and coordination of these projects.
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Coordinates, under guidance, with internal functional departments to ensure. Supports the coordination of feasibility activities, as required, in accordance with. MoH, EC, additional special national local applications if applicable, e.g. gene.
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Various site start-up activities are aligned with submissions activities and. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to. current regulatory guidelines as applicable to services provided.
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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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