Early Clinical Scientist

Parexel•Southport, NC

About The Position

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 exciting opportunity for a Clinical Scientist! The Early Clinical Scientist (ECS) may lead or support an early phase clinical study or studies, depending on size/complexity. The ECS is accountable for the clinical/scientific execution of the protocol.

Requirements

MS Office Suite Experience Required– including Word, Excel, Power Point, and Teams
Strong team collaboration, leadership, communication (written and verbal), issue identification and resolution skills
Proficient in written and spoken English
Proficient in local language (as applicable)
Ability to manage multiple projects and varied tasks and prioritize workload with attention to detail
Ability to manage complex operations and projects under accelerated timelines
Ability to partner effectively with internal and external teams to achieve results
Ability to quickly develop a working scientific knowledge of different therapeutic areas
Ability to build knowledge and skills to effectively manage additional processes/procedures
Experience in managing CROs from the Sponsor side for Phase 1 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.
Reviewing the following: protocol, ICF, IB, CSR, biomarker process, site and medical monitoring plans, risk assessment, protocol deviations
Understanding of clinical research development process from program planning to regulatory submission
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

Responsibilities

Responsible for coordinating the design, planning and execution of early phase clinical trials in collaboration 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 trial and program projects including team activities (i.e. meetings, document/collaborative workspace management, etc.)
Manages internal/external team performance to achieve project objectives and resolves project performance issues if they arise
Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues
Monitors clinical safety assessment and risk management of compounds
Provides risk assessment and contingency planning, under accelerated timelines
Reviews and interprets clinical data
May conduct on-site study monitoring, including site training and supervision of complex, novel endpoint/biomarker collection processes
Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports and 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.)
May be required to review budgets and approve invoices for payments to vendors.
Complies with required training curriculum
Completes timesheets accurately as required
Submits expense reports as required
Updates CV as required
Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements