Early Clinical Scientist

Parexel; Honolulu (HI); Teletrabalho; USD 90 000 - 130 000; Tempo integral

Resumo da oferta

Parexel is seeking an Early Clinical Scientist to lead or support early phase studies, ensuring clinical/scientific execution of the protocol. The ECS collaborates with internal and external teams, monitors trial safety and data, and authors critical protocol documents and reports.

The role requires experience with CRO management, strong writing skills, and the ability to handle multiple projects under tight timelines while adhering to GCP/ICH standards.

Qualificações

• Experience coordinating early phase clinical trials, with responsibility for clinical/scientific execution of protocols.
• Experience managing CROs from Sponsor side for Phase 1 trials is preferred.
• Knowledge of GCP, ICH guidelines and regulatory requirements.
• Ability to manage multiple projects and teams under accelerated timelines.

Responsabilidades

• Coordinate design, planning and execution of early phase clinical trials with Clinical Director and team.
• Provide oversight of trials across programs to ensure data validity and protocol compliance.
• Co-author protocol concepts, Investigator's Brochures, and study reports as needed.
• Develop study operational documents (sOPs, ICFs, monitoring plans).
• Review budgets and vendor invoices when required.

Conhecimentos

MS Office

Team leadership

Communication skills

English proficiency

Multi-project management

Cross-functional collaboration

Scientific writing

GCP/ICH knowledge

Pharmacology knowledge

Strategic planning

Formação académica

Bachelor's degree in Life Sciences

Master's degree in Life Sciences

PhD or doctorate in Life Sciences

Ferramentas

CTMS

eTMF systems

Descrição da oferta de emprego

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.