Early Clinical Scientist

Parexel; Olympia (WA); Remote; USD 120,000 - 160,000; Full time

Job summary

Parexel FSP has an 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. Parexel FSP expects you to coordinate design, planning and execution of early phase trials with the Clinical Director and team, oversee such trials to ensure data validity, and develop study documents.

Qualifications

• Experience managing CROs from sponsor side 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 (regulatory, data managers, etc).
• Understanding clinical research development from planning to regulatory submission.
• Scientific, medical and/or safety writing and reporting.
• Knowledge of GCP, ICH guidelines and regulatory requirements.
• Familiarity with early drug development processes.

Responsibilities

• Coordinate design, planning and execution of early phase trials with Clinical Director and team.
• Oversee trials to ensure excellence in execution and data validity.
• Manage trial and program projects and team activities.
• Monitor ongoing trials to identify and mitigate issues.
• Co-author clinical sections of protocols and study documents.
• Develop study operational documents (site monitoring plan, consent, etc.).
• Review budgets and approve vendor invoices when needed.

Skills

MS Office

Leadership

Communication

English proficiency

Project management

Cross-functional collaboration

Problem solving

Education

Life Sciences degree

Bachelors + 7 years experience

Masters + 5 years experience

PhD or doctorate + 1 year

Tools

CTMS

TMF systems

Job description

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.