Regional Clinical Scientist
hace 4 semanas
At Icon, we are seeking a highly skilled Regional Clinical Scientist to join our team. As a key member of our clinical operations team, you will play a critical role in supporting the execution of clinical trials and ensuring the highest level of quality and safety.
Key Responsibilities:- Provide scientific and clinical support to ongoing early and late stage clinical trials, with a focus on protocol-specific, in-life clinical data monitoring activities.
- Work closely with the Study Medical Monitor/Study Clinical Scientist to ensure seamless communication and collaboration.
- Conduct daily medical surveillance of laboratory & ECG alerts, including review of eligibility criteria as appropriate.
- Provide analytical support of clinical trial data, including assessment and follow-up of issues relating to protocol conduct and/or individual subject safety.
- Generate study safety events trackers, periodic medical monitoring reports, and safety reviews in line with the needs of the study.
- Participate in cross-functional study execution team activities relating to clinical data review.
- Contribute to ICFs, training documents, and other clinical and regulatory documents under the direction of the Medical Monitor/Study Clinical Scientist as applicable.
- Interact with internal and external stakeholders (study sites, vendors, etc.) in support of clinical trial objectives related to subject safety and clinical data monitoring.
- Life sciences degree (BS, MS, or Ph.D.) with clinical or pre-clinical research experience in the pharmaceutical industry or healthcare setting.
- Experience in analysis and interpretation of clinical data (including safety and efficacy); working knowledge of GCP and clinical trial execution.
- Experience working with clinical trial sites.
- Experience in all stages of drug development.
- Ability to make independent, timely, and appropriate decisions.
- Ability to handle multiple projects at a time and have a strong attention to detail.
- Excellent oral and written communication skills and solid computer/analytical skills.
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
- High level of organizational and project management skills.
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