Early Clinical Scientist – Translational Medicine

Parexel

. Coordinate the design, planning, and execution of early-phase clinical trials with the Clinical Director and internal/external team members .

Posted 9/23/2026full-timeRemote • New York • United StatesJuniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing early-phase clinical trials, ensuring compliance with GCP and ICH guidelines, and effectively collaborating with cross-functional teams. Proficient in authoring clinical documents and conducting oversight to maintain data integrity and patient safety.

Highest-signal resume keywords

Clinical Trial ManagementGCP KnowledgeProtocol AuthoringTeam LeadershipRisk Assessment

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Management SystemsTrial Master File SystemsScientific WritingData InterpretationProject ManagementRegulatory SubmissionBiomarker ProcessesSite MonitoringOperational Document DevelopmentTherapeutic Area Knowledge

Soft Skills

Team CollaborationCommunicationIssue ResolutionLeadership

Tools & Technologies

Microsoft Teams

Industry Keywords

Clinical TrialsICH GuidelinesGCPLife SciencesCRO ManagementClinical Research DevelopmentRisk ManagementPatient Safety

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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