Early Clinical Scientist

Parexel; Lincoln (NE); À distance; USD 110 000 - 140 000; Plein temps

Résumé du poste

Parexel is seeking an Early Clinical Scientist to lead or support early phase studies. You will be accountable for the clinical execution of the protocol and coordinate with Clinical Director and cross-functional teams.

This role emphasizes scientific rigor, risk management, and compliance with ICH-GCP standards. Ideal candidates have CRO management experience for Phase 1 trials, familiarity with CTMS/TMF, and strong communication skills.

Qualifications

• Experience managing CROs from the Sponsor for Phase 1 trials.
• Use of Clinical Trial Management and Trial Master File systems.
• Authoring Protocol Concepts.
• Facilitating a Trial Team with cross functional partners.
• Reviewing protocol, ICF, IB, CSR, biomarker processes and monitoring plans.
• Understanding clinical research development from planning to regulatory submission.
• Scientific, medical and/or safety writing ability.
• Knowledge of GCP, ICH guidelines and regulatory requirements.

Responsabilités

• Coordinate design, planning and execution of early phase trials with Clinical Director and teams.
• Oversee trials across programs and ensure excellent execution and data validity.
• Monitor safety assessment and risk management under accelerated timelines.
• Co-author clinical sections of protocols, brochures, and study reports.
• Develop study operational documents (site monitoring plan, informed consent).
• Review budgets and approve invoices for vendors.

Connaissances

MS Office

Team collaboration

Communication skills

English proficiency

Time management

Project management

Cross-functional collaboration

Scientific knowledge

Formation

Life Sciences degree

Bachelor's degree + 7+ years experience

Master's degree +5 years experience

PhD or doctorate +1 year experience

Description du poste

Parexel FSP has exciting opportunity for a Clinical Scientist! The Early Clinical Scientist (ECS) may lead or support an early phase clinical study or studies, depending on size/complexity. The ECS is accountable for the clinical/scientific execution of the protocol.

Key Accountabilities:

Oversight/Leadership

• Responsible for coordinating the design, planning and execution of early phase clinical trials in collaboration with the Clinical Director, and internal/external team members
• Oversees trials within and/or across program(s)/therapeutic areas and ensures excellence in execution/compliance to support study objectives and data validity
• Manages trial and program projects including team activities (i.e. meetings, document/collaborative workspace management, etc.)
• Manages internal/external team performance to achieve project objectives and resolves project performance issues if they arise
• Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues

Clinical Trial Operational Delivery

• Monitors clinical safety assessment and risk management of compounds
• Provides risk assessment and contingency planning, under accelerated timelines
• Reviews and interprets clinical trial data
• May conduct on-site study monitoring, including site training and supervision of complex, novel endpoint/biomarker collection processes
• Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports and ensures documents are completed in accordance with applicable standards
• Develops study operational documents with input from team members (e.g. site monitoring plan, study operations manual, informed consent, etc.)
• May be required to review budgets and approve invoices for payments to vendors.

Compliance with Parexel Standards

• Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

• MS Office Suite Experience Required- including Word, Excel, Power Point, and Teams
• Strong team collaboration, leadership, communication (written and verbal), issue identification and resolution skills
• Proficient in written and spoken English
• Proficient in local language (as applicable)
• Ability to manage multiple projects and varied tasks and prioritize workload with attention to detail
• Ability to manage complex operations and projects under accelerated timelines
• Ability to partner effectively with internal and external teams to achieve results
• Ability to quickly develop a working scientific knowledge of different therapeutic areas
• Ability to build knowledge and skills to effectively manage additional processes/procedures
• Ability to build knowledge and skills to effectively manage additional processes/procedures

Knowledge and Experience:

• 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

Education:

• Degree in Life Sciences
• Bachelor's degree and ≥7 years related* experience OR
• Master's degree and ≥5 years related* experience OR
• PhD or doctorate degree and ≥1 year related experience

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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.