Company:  Confidential

Job Title: Clinical Scientist – Contract / Oncology

Job Number: 81525

Location: Remote, US

Job Description

Responsibilities

* Conduct high-quality clinical data reviews and identify clinical data insights through ongoing patient-level review and trend analysis. This supports interim analyses, database and post-lock activities, and the resolution of scientific and medical issues throughout the study lifecycle. * Enhance the quality of reviews and insights with a focus on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identifying cases for medical review. * Contribute to the development and creation of clinical trial protocols, adhering to high scientific and clinical standards and applicable regulations. Collaborate closely with the clinical lead to identify, formulate, and implement amendments to the clinical protocol. * Participate in creating study-level documents, including the preparation of clinical sections for key regulatory documents such as Investigator’s Brochures, briefing books, safety updates, and submission dossiers. Assist in the review and writing of clinical trial documents for CTR activities and publications, if applicable. * Support pharmacovigilance activities, including contributing to aggregate reports, patient narratives, and attending pharmacovigilance monitoring meetings. * Aid in regulatory activities, such as preparing for meetings with regulatory agencies.

Required Skills

* Over 3 years of experience as a Clinical Trial Scientist or in a comparable role. * Strong knowledge of Good Clinical Practice (GCP) and drug development processes, ideally from Phase 1 to Phase 3, with experience in Oncology or Immuno-Oncology being highly desirable. * Proficient in the setup, organization, and execution of global clinical studies within a pharmaceutical company or contract research organization (CRO), or equivalent experience in an academic research institution. * In-depth understanding of clinical data collection and reporting principles, with demonstrated proficiency in using systems and tools (e.g., EDC systems, Excel) for data collection, analysis, and reporting. * Ideally, some experience in improving and accelerating processes, systems, and tools, with a focus on driving continuous improvement.

Application Deadline: 2024-08-12

 

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