At a glanceSummarised by Seekless from the posting.
Must have19
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
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
MS Office Suite Experience – 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
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
Eligibility1
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Skills
MS Office
Word
Excel
PowerPoint
Teams
Clinical Trial Management systems
Trial Master File systems
When our values align, there’s no limit to what we can achieve.
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.
Key Accountabilities:
Oversight/Leadership
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Responsible for coordinating the design, planning and execution of early phase clinical trials in collaboration with the Clinical Director, and internal/external team members
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Oversees trials within and/or across program(s)/therapeutic areas and ensures excellence in execution/compliance to support study objectives and data validity
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Manages trial and program projects including team activities (i.e. meetings, document/collaborative workspace management, etc.)
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Manages internal/external team performance to achieve project objectives and resolves project performance issues if they arise
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Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues
Clinical Trial Operational Delivery
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Monitors clinical safety assessment and risk management of compounds
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Provides risk assessment and contingency planning, under accelerated timelines
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Reviews and interprets clinical trial data
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May conduct on-site study monitoring, including site training and supervision of complex, novel endpoint/biomarker collection processes
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Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports and ensures documents are completed in accordance with applicable standards
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Develops study operational documents with input from team members (e.g. site monitoring plan, study operations manual, informed consent, etc.)
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May be required to review budgets and approve invoices for payments to vendors.
Compliance with Parexel Standards
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Complies with required training curriculum
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Completes timesheets accurately as required
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Submits expense reports as required
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Updates CV as required
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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
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.