Early Clinical Scientist – Translational Medicine
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Job Description
Early Clinical Scientist coordinating early-phase clinical trials for Parexel’s clinical development services. Overseeing safety, data validity, CRO performance, and trial documentation.
Responsibilities:
- Coordinate the design, planning, and execution of early-phase clinical trials with the Clinical Director and internal/external team members
- Oversee trials within and/or across programs or therapeutic areas
- Ensure excellence in execution and compliance to support study objectives and data validity
- Manage internal and external team performance to achieve project objectives
- Resolve project performance issues
- Ensure appropriate clinical safety assessment and risk management of compounds
- Conduct real-time oversight of ongoing trials to identify and mitigate patient, study design, data, or study conduct issues
- Review and interpret clinical trial data
- Potentially conduct on-site study monitoring, including site training and supervision of complex, novel endpoint/biomarker collection processes
- Apply knowledge of GCP, ICH guidelines, and regulatory requirements for clinical development
- Co-author clinical sections of protocols, clinical investigator brochures, and clinical study reports
- Develop study operational documents, including site monitoring plans, study operations manuals, and informed consents
- Manage trial and program projects, team activities, risk assessment, and contingency planning under accelerated timelines
- Build knowledge and skills to manage additional early drug development processes and procedures
Requirements:
- 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 protocols, ICFs, IBs, CSRs, biomarker processes, site and medical monitoring plans, risk assessments, and protocol deviations
- Working in Microsoft Teams
- Understanding of the clinical research development process from program planning to regulatory submission
- Ability to quickly develop 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, issue identification, and resolution skills
- Knowledge of GCP, ICH guidelines, and regulatory requirements
- Degree in Life Sciences
- Bachelor’s degree and ≥7 years related experience, or Master’s degree and ≥5 years related experience, or PhD/doctorate degree and ≥1 year related experience
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