Clinical Scientist
Kelly Science & Clinical FSP is seeking a Clinical Scientist for a long-term remote engagement supporting a global pharmaceutical client. This individual will work closely with the Clinical Scientist Protocol Lead and study team to support the clinical and scientific execution of clinical studies.
Key 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
Qualifications
- 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
- Experience reviewing patient data and resolving discrepancies involving adverse events, laboratory results, endpoints, and safety data preferred
- 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