Clinical Research Scientist
hace 1 mes
Icon is seeking a highly skilled Clinical Research Scientist to join our team. As a key member of our clinical operations team, you will provide scientific and clinical support for ongoing early and late stage clinical trials. Your expertise will be instrumental in ensuring the successful execution of clinical studies and the delivery of high-quality clinical data.
Key Responsibilities- Support the Study Clinical Scientist in medical surveillance and medical monitoring activities, including review of eligibility criteria and daily medical surveillance of laboratory & ECG alerts.
- Provide analytical support of clinical trial data, including assessment and follow-up of issues relating to protocol conduct and/or individual subject safety.
- Gather, review, and provide preliminary assessments of medical surveillance events to the Study Clinical Scientist and the Study Medical Monitor.
- 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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