Clinical Scientist

This is a fully remote position, open to applicants in United States, +4 more locations.

📋 Description

• Formulate clinical data review strategies for designated studies

• Work in collaboration with cross-functional team members to ensure accurate collection and reporting of protocol-defined variables

• Perform ongoing assessments and analyses of clinical data, including components related to efficacy and safety, utilizing listings, tables, figures, graphs, and EDC as necessary

• Monitor and analyze potential safety events in conjunction with Pharmacovigilance and Medical Monitoring

• Engage in discussions regarding potential modifications to studies or strategies based on clinical data evaluations

• Prepare data summary presentations for Safety Review Committee Meetings and Data Review Meetings, with assistance from the Director

• Communicate key data trends and findings to the Medical Monitor, Study Team, and Client

• Conduct queries on EDC data as necessary during clinical reviews, ensuring prompt follow-up and identification of possible protocol deviations

• Collaborate with vendors and study team members to guarantee precise endpoint reporting

• Act as a liaison for site staff and monitors regarding protocol and clinical inquiries

• Partner with Data Management on CRF design, CRF instructions, and data quality initiatives

• Evaluate data-driven sections of regulatory and clinical reporting documents, including CSRs, INDs, NDAs/BLAs, annual reports, and IBs

• Offer scientific writing assistance, which includes patient narratives, abstracts, posters, and presentations

• Mentor and provide training for junior staff

• Leverage visual analytics tools to interpret and convey data insights

⛳️ Requirements

• In-depth knowledge of clinical development processes and study design principles

• Comprehensive understanding of product profiles and safety considerations

• Expertise in clinical data analysis, interpretation, and evaluation of clinical relevance in human clinical trials within the pertinent therapeutic area

• Proficient with electronic data capture systems and data visualization tools

• Strong grasp of GCP, ICH guidelines, and regulatory standards

• Exceptional written and verbal communication, as well as presentation abilities

• Strong organizational, analytical, and problem-solving skills

• Capacity to manage multiple priorities and adjust to evolving demands

• Excellent interpersonal skills with the ability to collaborate across diverse teams and levels

• Proven capability to work autonomously and as part of a team

• Good judgment and decision-making capabilities

• Willingness to travel as necessary

• Advanced clinical or scientific degree preferred (e.g., PharmD, PhD, MSN, MPH) with 8+ years of industry-related experience in Oncology

• OR Bachelor's degree with 12+ years of relevant industry/research experience in the applicable therapeutic area, including data review and interpretation

• Proficiency in Microsoft Office Suite

• Familiarity with EDC systems and data visualization platforms

🏝️ Benefits

• Competitive benefits package based on location

• Transparent compensation and pay equity