Note: The job is a remote job and is open to candidates in USA. AllSTEM Connections is seeking a contract Senior Clinical Research Scientist to support global oncology clinical development. The role contributes to development strategy and leads or co-leads clinical trials, while supporting regulatory documentation, medical data review, study start-up, site engagement, and cross-functional collaboration.

Responsibilities

• Contribute to the implementation of global development strategy by leading or co-leading one or more clinical trials
• Support development of program strategy and Clinical Development Plans (CDP)
• Provide oversight of clinical development activities in collaboration with the Medical Director and cross-functional teams
• Contribute to development of clinical and regulatory documents including:
• Protocols
• Informed Consent Forms (ICF)
• Investigator’s Brochures (IB)
• Annual safety updates
• Study reports
• Regulatory submission documents
• Support preparation of registration dossiers
• Participate in development of eCRFs and eCRF completion guidelines
• Provide scientific input into key data management deliverables (e.g., database lock activities)
• Lead development of the Medical Data Review Plan (MDRP)
• Perform ongoing data review and summarize efficacy and safety data for interpretation
• Provide medical input for country and site selection
• Conduct feasibility assessments
• Engage with Key Opinion Leaders (KOLs)
• Participate in study start-up activities including protocol training and document review
• Prepare charters and coordinate internal/external committee meetings, including:
• Dose Escalation Committees
• Data Monitoring Committees (DMC)
• Steering Committees
• Safety Committees
• Prepare presentations for:
• Investigator Meetings
• CRO/CRA training sessions
• Site Initiation Visits (SIVs)
• Serve as liaison to project teams and CROs
• Provide input into study plans
• Support publication development in coordination with Scientific Communications
• Mentor junior Clinical Research Scientists as needed

Skills

• PhD, PharmD, MS, or equivalent degree in medical, biological, pharmaceutical sciences, or related discipline
• Minimum 10+ years of experience in clinical research
• At least 3+ years of drug development experience
• Strong experience with RECIST
• Experience in study start-up activities, including:
• Protocol training
• Document review and authoring
• Site contact and feasibility assessments
• Slide development and presentation experience
• Eligibility review experience
• Vendor management and oversight experience
• Experience working in a project-oriented, matrixed team environment
• Strong written and verbal communication skills
• GI cancer experience preferred
• Preferably in oncology/hematology

Benefits

• Remote work

Company Overview

Company H1B Sponsorship