Early Clinical Scientist

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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.