Early Clinical Scientist

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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