Arama sonuçları: 13 ilan
...well as active presentation as applicable
Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements
Support audits and inspections at sites and affiliate, as applicable
You are:
Bachelor or Master’s degree...
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...with Clinical Team Managers, Start-Up Leads and Clinical Research Associates.
Working with the wider PRA project team including Regulatory, Contracts and Project Management.
Performing investigative site recruitment and evaluation.
Essential document collection,...
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...described in the SAP and specifications.
• May lead complex or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of...
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yıllık 40000-60000 €
...Ensure data quality, integrity, and security by implementing best practices for data governance, access control, and compliance with regulatory requirements (e.g., GDPR).
Monitor and optimize the performance of data pipelines and infrastructure to meet scalability,...
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...holding yourself and others accountable. You
Essential Functions:
Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers...
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...contribute to the achievement of business objectives at GPD or WSR Functional Line level - e.g., WSR Worldwide Safety, WSR Worldwide Regulatory Operations, GPD Clinical Development & Operations, etc.
#LI-REMOTE
#LI-TS2
You are:
5+ years of experience in...
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...from either a pharmaceutical company or a CRO environment.
A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
You will be educated to degree level, have equivalent experience or be a licensed healthcare...
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...user onboarding and account management across our suite of services. These include KYC/AML processes, entitlements management and regulatory reporting. The team is instrumental in ensuring a compliant and efficient user onboarding experience, enabling over a million...
...creating, documenting & refining the SW engineering process
Nice to Have
Life sciences domain knowledge, especially the regulatory area
Experience with Atlassian products like Jira
Manage a platform QA team
Manage an applications development QA team...
...yearly budget for your individual learning and development goals.
At Xapo, we prioritize consumer protection and adhere to regulatory requirements by ensuring that all Xapiens are accountable for upholding principles of fair treatment, transparency, and ethical conduct...
...Ensuring staff fulfill their responsibilities in accordance with ICON’s policies, procedures, SOPs, ICH-GCPs, and other relevant regulatory requirements
Liaising with other functional managers to ensure consistency within the company
Maintaining utilization of all...
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...qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate...
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...EXPERTISE
Acts as country operations subject matter expert (SME) by demonstrating knowledge of country operational processes, regulatory operations, and industry clinical research environment. May use other in country SMEs for support (e.g., regulatory intelligence...
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