Job Description

We are seeking a motivated Clinical Scientist to join our clinical development team and contribute to the advancement of innovative therapeutic programs. This role provides an excellent opportunity to gain hands-on experience in clinical trial design and execution while working alongside experienced clinical development professionals in a dynamic biotech/pharmaceutical environment.

Key Responsibilities

• Monitor, review, and summarize safety and efficacy data in 1 or more ongoing studies
• Work in close collaboration with the clinical team to ensure translation of the clinical protocol (and amendments) into operational deliverables, including but not limited to performing ongoing review and analysis of clinical study data and preparing/reviewing study plans (i.e., Medical Monitoring, Medical Data Review, Safety Management, CRF Completion Guidelines, etc.)
• Respond to study questions from sites and/or vendors, with study medical monitor or Clinical Development supervision where needed
• Perform literature search and critically review and summarize the relevant scientific, drug development, and medical literature to support new clinical trial design as well as the development of clinical and/or regulatory documents
• Support preparation of scientific material
• Contribute to the development of SOPs and associated guidelines and templates
• Participate in cross-functional team meetings with members from clinical operations, safety, regulatory, biostatistics and data management  

​​​​​​​ Qualifications

• Degree in life sciences or health-related field
• Minimum requirement: at least 2-4 years’ industry experience (clinical research preferred)
• Therapeutic areas of expertise must include oncology.
• Entry-level experience with data cleaning, visualization, and basic statistical analysis (Excel mandatory, R optional)
• Knowledge of the International Council of Harmonization (ICH), GCP, and other relevant regulatory guidelines.
• Ability to analyze, interpret and socialize data to internal and external stakeholders
• Strong communication, presentation, analytic, and strategic capabilities and ability to effectively collaborate with medical experts.
• Ability to think strategically and creatively, function independently, deliver on timelines, and contribute strategic insights

Job Tags

Full time,

Similar Jobs