Early Clinical Scientist

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

• 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

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

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