Early Clinical Scientist
United States
Job Description
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.
Key Accountabilities:
Oversight/Leadership
Clinical Trial Operational Delivery
Compliance with Parexel Standards
Skills:
Knowledge and Experience:
Education:
#LI-KW1
#LI-REMOTE
Key Accountabilities:
Oversight/Leadership
- 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
Clinical Trial Operational Delivery
- Monitors clinical safety assessment and risk management of compounds
- Provides risk assessment and contingency planning, under accelerated timelines
- Reviews and interprets clinical trial 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.
Compliance with Parexel Standards
- 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
Skills:
- 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
- Ability to build knowledge and skills to effectively manage additional processes/procedures
Knowledge and Experience:
- 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
Education:
- 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
#LI-KW1
#LI-REMOTE
Apply
Similar Jobs
Scientist I, Chemistry
Scientist I, Chemistry Southern Research + YouDiscover a career where yo...
Scientist, Analytical Development
The Role In this role, you will develop mechanism-driven bioassays for e...
Application Scientist Co-Op (Spring 2027)
Job TitleApplication Scientist Co-Op (Spring 2027)Location(s)Akron About...
Scientist I, Platform Innovation
About us Basecamp Research is building frontier AI for therapeutic desig...