Remote Early-Phase Clinical Scientist Study Lead

Parexel; Madison (WI); Remote; USD 90,000 - 130,000; Full time

Job summary

Parexel is seeking an Early Clinical Scientist to lead or support early phase clinical trials, ensuring scientific execution of the protocol. The role involves coordinating design and execution with the Clinical Director and cross-functional teams, while maintaining data validity and regulatory compliance.

The candidate will monitor safety, assess risks, co-author protocol sections, and develop operational documents. Strong English and cross-functional collaboration are essential.

Qualifications

• Experience in managing CROs from the Sponsor side for Phase 1 clinical trials.
• Use of Clinical Trial Management and Trial Master File systems
• Authoring Protocol Concepts
• Facilitating a Trial Team including cross functional partners such as regulatory, clinical supplies managers, data managers, statisticians, programmers, procurement, etc.
• Reviewing the following: protocol, ICF, IB, CSR, biomarker process, site and medical monitoring plans, risk assessment, protocol deviations
• Understanding of clinical research development process from program planning to regulatory submission
• Scientific, medical and/or safety writing and reporting (at least one is required)
• Knowledge of GCP, ICH guidelines and regulatory requirements
• Familiarity with early drug development processes

Responsibilities

• Coordinate design, planning and execution of early phase clinical trials with the Clinical Director and team members.
• Oversee trials to ensure objective achievement and data validity across programs.
• Manage trial and program projects including meetings and document management.
• Lead internal/external team performance to meet objectives and resolve issues.
• Provide real-time oversight to identify and mitigate study issues.
• Co-author clinical sections of protocols and investigator brochures and ensure standards compliance.
• Develop study operational documents with team input (site monitoring plan, informed consent, etc.).
• May review budgets and approve invoices for vendor payments.

Skills

MS Office Suite

Word

Excel

PowerPoint

Teams

English proficiency

Project management

Cross-functional collaboration

Education

Degree in Life Sciences

Bachelor's degree with 7+ years related experience

Master's degree with 5+ years related experience

PhD or doctorate with 1+ year related experience

Tools

CTMS

Trial Master File systems

Job description

Parexel is seeking an Early Clinical Scientist to lead or support early phase clinical trials, ensuring scientific execution of the protocol. The role involves coordinating design and execution with the Clinical Director and cross-functional teams, while maintaining data validity and regulatory compliance.

The candidate will monitor safety, assess risks, co-author protocol sections, and develop operational documents. Strong English and cross-functional collaboration are essential.