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Regional Clinical Scientist
hace 2 meses
We are seeking a highly skilled Regional Clinical Scientist to join our team at ICON. As a key member of our clinical operations team, you will play a critical role in providing scientific and clinical support for our clinical trials.
Key Responsibilities- Medical Surveillance and Monitoring: Support the Study Clinical Scientist in medical surveillance and medical monitoring activities, including daily review of laboratory and ECG alerts, and assessment of eligibility criteria as necessary.
- Clinical Data Analysis: Provide analytical support for clinical trial data, including assessment and follow-up of issues related to protocol conduct and individual subject safety.
- Medical Surveillance Event Tracking: Gather, review, and provide preliminary assessments of medical surveillance events to the Study Clinical Scientist and Study Medical Monitor.
- Study Safety Reports: Generate study safety events trackers, periodic medical monitoring reports, and safety reviews in line with the needs of the study.
- Cross-Functional Collaboration: Participate in cross-functional study execution team activities related to clinical data review.
- Document Development: Contribute to the development of ICFs, training documents, and other clinical and regulatory documents under the direction of the Medical Monitor/Study Clinical Scientist.
- Stakeholder Engagement: Interact with internal and external stakeholders, including study sites and vendors, to support clinical trial objectives related to subject safety and clinical data monitoring.
- Education: Life sciences degree (BS, MS, or Ph.D.) with clinical or pre-clinical research experience in the pharmaceutical industry or healthcare setting.
- Clinical Data Experience: Experience in analysis and interpretation of clinical data, including safety and efficacy, and working knowledge of GCP and clinical trial execution.
- Study Site Experience: Experience working with clinical trial sites.
- Drug Development Experience: Experience in all stages of drug development.
- Decision-Making and Problem-Solving: Ability to make independent, timely, and appropriate decisions.
- Project Management: Ability to handle multiple projects at a time and have a strong attention to detail.
- Communication and Collaboration: Excellent oral and written communication skills and solid computer/analytical skills.
- Teamwork and Adaptability: Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
- Organizational and Project Management Skills: High level of organizational and project management skills.
- Flexibility: Flexible to accommodate changes in team and project needs.
