Early Clinical Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

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

• Supervise trials across various programs and/or therapeutic areas, ensuring high standards of execution quality, compliance, study objectives, and data integrity.

• Manage trial and program projects, including team activities, meetings, and the organization of documents/collaborative workspaces.

• Oversee the performance of both internal and external teams, addressing any project performance challenges that arise.

• Provide real-time supervision of ongoing trials to detect and mitigate issues related to patients, study design, data, and trial conduct.

• Monitor clinical safety evaluations and manage compound risk effectively.

• Deliver risk assessments and develop contingency plans under tight timelines.

• Review and analyze clinical trial data.

• Potentially conduct on-site study monitoring, including training and supervising the collection of complex endpoints/biomarkers.

• Co-author clinical sections of protocols, clinical investigator brochures, and clinical study reports.

• Create operational documents for studies, such as site monitoring plans, study operations manuals, and informed consent forms.

• Review budgets and approve vendor invoices as necessary.

• Complete mandatory training, timesheets, expense reports, and updates to CVs.

• Stay informed about and adhere to Parexel processes, ICH-GCPs, and relevant requirements.

⛳️ Requirements

• Proficiency in the MS Office Suite is essential, including Word, Excel, PowerPoint, and Teams.

• Strong skills in team collaboration, leadership, effective written and verbal communication, issue identification, and resolution.

• Command of written and spoken English is required.

• Proficiency in the local language, as necessary.

• Capability to manage multiple projects and diverse tasks while prioritizing workload with meticulous attention to detail.

• Ability to oversee complex operations and projects within accelerated timelines.

• Effectiveness in partnering with both internal and external teams.

• Quick adaptability to develop working scientific knowledge across various therapeutic areas.

• Experience in managing CROs from the Sponsor perspective for Phase 1 clinical trials.

• Familiarity with Clinical Trial Management and Trial Master File systems.

• Experience in authoring Protocol Concepts.

• Experience in facilitating cross-functional Trial Teams.

• Experience in reviewing protocols, ICFs, IBs, CSRs, biomarker processes, site and medical monitoring plans, risk assessments, and protocol deviations.

• Understanding of the clinical research development process, from program planning to regulatory submission.

• Experience in scientific, medical, and/or safety writing and reporting; at least one is required.

• Knowledge of GCP, ICH guidelines, and regulatory requirements.

• Familiarity with early drug development processes.

• A degree in Life Sciences is required.

• A Bachelor’s degree with ≥7 years of relevant experience, or a Master’s degree with ≥5 years of relevant experience, or a PhD/doctorate degree with ≥1 year of relevant experience.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health benefits, including medical, dental, and vision coverage.

• Opportunities for professional development and continuous learning.

• Flexible working hours and potential remote work options.

• Supportive and inclusive work environment that values diversity.