5-7 years of experience managing CROs for Phase 1 clinical trials from the Sponsor perspective.
Proficiency in Clinical Trial Management and Trial Master File systems.
Experience authoring protocol concepts and operational documents.
Ability to facilitate collaboration among regulatory, clinical, data management, and technical roles.
Experience managing multiple projects concurrently with strict timelines.
Strong skills in reviewing clinical trial documents and data analysis.
Familiarity with Microsoft Teams for project management and communication.
Responsibilities
Coordinate design, planning, and execution of early phase clinical trials with internal and external teams.
Oversee trial performance and ensure compliance with study objectives.
Manage real-time safety assessments and risk management of clinical compounds.
Conduct oversight of trials to identify and resolve issues in trial execution.
Co-author and ensure compliance of clinical-related documentation such as protocols and reports.
Manage project schedules and perform risk assessments under accelerated timelines.
Develop study operational documents and training materials for site staff.
Benefits
Opportunity to work with cross-functional teams in a fast-paced environment.
Access to ongoing professional development and career advancement.
Exposure to a variety of therapeutic areas and innovative clinical trials.
Flexibility in managing multiple projects and diverse responsibilities.
Full 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:
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 67 years related* experience OR
Master's degree and 65 years related* experience OR
PhD or doctorate degree and 61 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).
