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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