Early Clinical Scientist- Translational Medicine -FSP
United States
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:
Education Minimum Requirement:
*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
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
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