About this opportunity
AllSTEM Connections lists this Senior Clinical Research Scientist opportunity in austin, Texas. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Job Duration: 6+ Months
Remote job
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
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
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.