Early Clinical Scientist- Translational Medicine -FSP

Parexel; Augusta (ME); Remote; USD 120,000 - 180,000; Full time

Job summary

Parexel is seeking an Early Clinical Scientist (ECS) to coordinate design, planning, and execution of early phase trials in collaboration with the Clinical Director and diverse teams. You will oversee trials to ensure alignment with objectives, data integrity, and regulatory compliance.

Responsibilities include authoring protocol concepts, managing trial documents, and leading cross-functional teams across regulatory, data, and clinical operations, with an emphasis on safety and risk management.

Qualifications

• Experience managing CROs from Sponsor side for Ph1 trials.
• Experience with CTMS and Trial Master File systems.
• Authoring Protocol Concepts.
• Ability to lead and coordinate cross-functional teams.

Responsibilities

• Coordinate design, planning and execution of Early Phase trials with clinical director.
• Oversee trials across programs and ensure compliance and data validity.
• Co-author protocols, investigator brochures, and study reports.
• Manage study documents and risk management processes.

Skills

Clinical trial management

Cross-functional leadership

Regulatory knowledge

GCP/ICH familiarity

Scientific writing

Project coordination

Team collaboration

Education

Life Sciences degree

7+ years CRO/ph1 experience

Master's degree or PhD beneficial

Tools

CTMS

Trial Master File systems

Microsoft Teams

Job description

Parexel FSP has an exciting opportunity for a Clinical Scientist!

The Early Clinical Scientist/ECS coordinates the design, planning and execution of early phase clinical trials 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 internal/external team performance to achieve project objectives and resolves project performance issues if they arise.

Ensures appropriate clinical safety assessment and risk management of compounds. Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues. Reviews and interprets clinical trial data. May conduct on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes. Applies thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.

Technical Writing & Communications

Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, 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.).

Project Management

Manages trial and program projects including team activities (i.e. meetings, document/collaborative workspace management, etc.), provides risk assessment and contingency planning, under accelerated timelines. Familiar with early drug development processes, building knowledge and skills to effectively manage additional processes/procedures.

Required Experience and Skills:

• Experience in managing CROs from the Sponsor side for Ph1 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.
• Managing multiple projects at a time
• Reviewing the following: protocol, ICF, IB, CSR, biomarker process, site and medical monitoring plans, risk assessment, protocol deviations
• Working in Microsoft Teams
• Understanding of clinical research development process from program planning to regulatory submission
• Able to quickly develop a working scientific knowledge of different therapeutic areas
• Ability to manage complex operations and projects under accelerated timelines
• Scientific, medical and/or safety writing and reporting (at least one is required)
• Ability to partner effectively with internal and external teams to achieve results
• Strong team collaboration, leadership, communication (written & verbal), issue identification and resolution skills
• Knowledge of GCP, ICH guidelines and regulatory requirements

Education Minimum Requirement:

• 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
• *e.g., knowledge of clinical trial management and trial execution; clinical site training/monitoring; medical and regulatory writing; OR equivalent experience with developing preclinical model experiments for drug candidates (protocol authoring, experiment execution/oversight, authoring experiment reports).

#LI-REMOTE

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.