Senior Clinical Research Scientist

Job Duration: 6+ Months

Remote job

Please read the information in this job post thoroughly to understand exactly what is expected of potential candidates.

Position Overview

We are seeking an experienced Senior Clinical Research Scientist (Contractor) to support global clinical development activities within oncology. The ideal candidate will have strong expertise in gastrointestinal (GI) cancers, RECIST criteria, and end-to-end clinical trial execution, including study start-up and vendor oversight.

This role will contribute to the implementation of global development strategy, leading or co-leading clinical trials across various stages of development in close collaboration with the Medical Director and cross-functional teams.

Key Qualifications

• 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 (preferably in oncology/hematology)
• GI cancer experience preferred
• 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

Core Responsibilities

Clinical Trial Leadership & Strategy

• 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

Regulatory & Documentation

• 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

Data & Medical Review

• 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

Study Start-Up & Site Engagement

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• 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

Committees & Presentations

• 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)

Cross-Functional Collaboration

• 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