Note: The job is a remote job and is open to candidates in USA. Kelly Science & Clinical FSP provides scientific and clinical staffing support for pharmaceutical clients. The Clinical Scientist will support the clinical and scientific execution of clinical studies by assisting with medical monitoring, reviewing patient and study data, managing protocol deviations, and coordinating with study stakeholders.
Responsibilities
- Assist the Clinical Scientist Protocol Lead and study team with the clinical/scientific conduct of clinical studies
- Support medical monitoring activities, adjudication, imaging data reconciliation, and preparation of study meeting materials
- Review clinical study data and assist with identification and resolution of data discrepancies and queries
- Support protocol deviation review and management
- Review patient data, including adverse events, laboratory results, endpoints, and other clinical information
- Support one or multiple clinical studies depending on study needs
- May lead a study or workstream with limited scope, such as survival follow-up
- Interact with internal and external stakeholders, including study sites and committees, to support clinical study objectives
Skills
- Degree in Life Sciences required (BS/BA/MS/PhD)
- Minimum of 2 years of pharmaceutical and/or clinical drug development experience within the last 5 years
- Experience may come from pharmaceutical/biopharmaceutical companies, CROs, hospitals, research sites, clinical trial units, or SMOs
- Experience reviewing and resolving study-related data issues, including queries and medical record/data review
- Ability to identify data discrepancies requiring clarification with clinical study sites
- Therapeutic-area experience required for Oncology positions; indication-specific experience preferred
- Strong written and verbal communication skills
- Proficiency with Microsoft Outlook, Word, Excel, and PowerPoint; OneNote experience preferred
- Experience reviewing patient data and resolving discrepancies involving adverse events, laboratory results, endpoints, and safety data preferred
Benefits
- Long-term remote engagement
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