Clinical Research Oversight Specialist
vor 2 Wochen
As an Oversight Monitor, you will be joining a leading clinical research organization, where you will play a critical role in ensuring the highest standards of quality and compliance in our clinical trials.
Key Responsibilities:- Develop and implement comprehensive oversight monitoring plans tailored to our organization's specific clinical trials and research activities.
- Perform onsite and remote oversight monitoring visits to assess protocol compliance, data accuracy, and monitoring visit oversight.
- Implement quality control measures and risk management strategies to proactively identify and mitigate potential risks.
- Prepare comprehensive oversight monitoring reports summarizing findings, recommendations, and corrective actions for management and regulatory agencies.
- Support local partnerships with internal and external stakeholders to enable country-focused delivery and execution of the R&D pipeline.
- Perform country, site, and CRO sponsor oversight activities to ensure high-quality execution of clinical trials and highlight local opportunities to drive operational excellence.
- Maintain study information on various databases and systems.
- Work with the strategic partner CRO and global teams to provide required information as part of defined country and site selection processes.
- Support the maintenance of accurate contact lists, calendar information, local clinical operational intelligence, and update tracking systems as needed.
- Bachelor's Degree (or equivalent) with 6-8 years of relevant healthcare experience in the pharma or clinical research industry.
- Scientific background.
- Experience in Oncology, Infectious Diseases/Vaccines, and/or Rare Diseases.
- Proficiency with medical terminology.
- Working knowledge of Local Regulations.
- Demonstrated working knowledge of ICH/GCP Guidelines.
- Excellent record-keeping skills and attention to detail.
- Experience conducting Site Selection, Initiation, Routine Monitoring, and Close-Out Visits both remotely and on-site.
- Fluent in English, both written and oral.
- Strong technical skills with CTMS, eCRF, eTMF.
- Competitive salary.
- A range of health insurance offerings to suit you and your family's needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
- Life assurance.
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
We are committed to providing an inclusive and accessible environment for all candidates. ICON is an equal opportunities employer and welcomes applications from diverse candidates. If you need a reasonable accommodation for any part of the application process, please let us know through the form below.
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