Clinical Research Associate
vor 17 Stunden
As an Oversight Monitor at Pharmiweb, you will be part of the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence.
Key Responsibilities:- Oversight Monitoring Plan Development: Develop a comprehensive oversight monitoring plan tailored to our organization's specific clinical trials and research activities.
- Onsite and Remote Oversight Monitoring: Perform both onsite and remote oversight monitoring visits to assess protocol compliance, data accuracy, monitoring visit report review, and monitoring visit oversight.
- Quality Control and Risk Management: Implement quality control measures and risk management strategies to proactively identify and mitigate potential risks.
- Reporting and Recommendations: Prepare comprehensive oversight monitoring reports summarizing findings, recommendations, and corrective actions for management and regulatory agencies.
- Country Level Support: Provide support for local partnerships with both internal and external stakeholders to enable the country-focused delivery and execution of the R&D pipeline.
- Clinical Trial Oversight: Perform country, site, and CRO sponsor oversight activities to ensure high-quality execution of clinical trials and highlight local opportunities to drive operational excellence.
- Database Management: Maintain study information on a variety of databases and systems.
- Global Collaboration: Work with the strategic partner CRO and global teams to provide required information as part of defined country and site selection processes.
- Operational Intelligence: Support the maintenance of accurate contact lists, calendar information, local clinical operational intelligence, and update tracking systems as needed.
- Education: Bachelor's Degree (or equivalent) with 6-8 years of relevant healthcare experience in the pharma or clinical research industry.
- Scientific Background: Experienced in Oncology, Infectious Diseases/Vaccines, and Rare Diseases.
- Medical Terminology: Proficiency with medical terminology.
- Regulatory Knowledge: Working knowledge of Local Regulations and ICH/GCP Guidelines.
- Technical Skills: Strong technical skills with CTMS, eCRF, and eTMF.
- Language: Fluent in English, both written and oral.
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, Pharmiweb offers a range of benefits, including various annual leave entitlements, health insurance, retirement planning, and a global Employee Assistance Programme.
We're committed to providing an inclusive and accessible environment for all candidates and employees. If you need a reasonable accommodation for any part of the application process, please let us know.
At Pharmiweb, diversity, inclusion, and belonging are fundamental to our culture and values. We're proud of our diverse workforce and the work we've done to become a more inclusive organization.
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