Senior Clinical Research Scientist

Job Title: Senior Clinical Research Scientist
Location: Princeton, New Jersey
Type: Contract
Compensation: $110 per hour
Work Model: Remote – offsite
Hours: 9:00 AM to 5:00 PM, 40 hours per week

Responsibilities

• Contribute to the implementation of the global development strategy, leading or co-leading clinical trials in various stages of development, and overseeing all aspects of clinical development working closely with the Medical Director and cross-functional teams to ensure high-quality, timely deliverables
• Develop program strategies for assigned trials/compounds and participate in the creation of the clinical development plan (CDP)
• Collaborate with the Medical Director to develop clinical and regulatory documents, including safety updates, registration dossiers, protocols, ICFs, IBs, study reports, and regulatory submissions to support registration and commercialization
• Assist in the development of case report forms (eCRFs), completion guidelines, and provide scientific support for data management activities such as database lock procedures
• Lead the development of the medical data review plan (MDRP), perform ongoing data reviews, and summarize efficacy and safety data for interpretation and analysis
• Provide medical input for country/site selection, feasibility assessments, and engage with KOLs
• Prepare charters and coordinate internal/external committee meetings, including presentation development for Dose Escalation Committees, DMCs, Steering Committees, and Safety Committees
• Participate in the development and review of study plans, serving as a liaison to project teams and CROs
• Contribute to the development of publications in coordination with Scientific Communications
• Prepare presentations for investigator meetings, CRO/CRA training, and site initiation visits (SIVs) as needed
• Mentor junior Clinical Research Scientists as required

Requirements

• PhD, PharmD, MS, or equivalent degree in medical, biological, pharmaceutical sciences, or related discipline
• Minimum 10 years of experience in clinical research, with at least 3 years in oncology drug development
• Proven experience working in a project-oriented, matrixed team environment
• Ability to work successfully under pressure in a fast-paced environment with tight timelines
• Strong collaboration and communication skills

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #568-Clinical