Early Clinical Scientist- Translational Medicine -FSP

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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:

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). EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™