Early Clinical Scientist- Translational Medicine -FSP
ATLAS MEDICAL SERVICES LTD. STI. · United States · 1 mo ago
RemoteRemoteResearchFull-time
We need to output only HTML fragment, with headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Remove boilerplate, navigation, etc.
We need to parse the job posting text.
Key sections:
- About This Role: description of role.
- Responsibilities: bullet points of duties.
- Required Experience And Skills: list of required experience and skills.
- Education Minimum Requirement: education.
- Benefits: there is a Benefits section later: "More Than A Job Benefits Benefits vary by country, but Parexel is passionate about our team’s overall wellness." That's vague; not specific. Also earlier there is "Benefits & Support" with bullet points: Flexible Work Program, Bravo Recognition Program, well-being. That seems specific enough? It says: "Explore the Flexible Work Program, our "Bravo" Recognition Program, and how we build our well-being in our supportive culture." That's somewhat specific but not detailed list. Might still count as Benefits section.
- Pay: not mentioned.
- Schedule: not mentioned (flexible work program mentions flexible arrangement but not schedule specifics). Could include Schedule? Probably not.
We need to include sections only if real specific content.
Let's extract:
About the role: The paragraph after "About This Role": "Parexel FSP has an exciting opportunity for a Clinical Scientist! The Early Clinical Scientist/ECS coordinates the design, planning and execution of early phase clinical trials 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 internal/external team performance to achieve project objectives and resolves project performance issues if they arise. Ensures appropriate clinical safety assessment and risk management of compounds. Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues. Reviews and interprets clinical trial data. May conduct on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes. Applies thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development."
That's substantive.
Responsibilities: Could be the bullet list after "Technical Writing & Communications", "Project Management". Actually the posting includes sections: "Technical Writing & Communications", "Project Management". Those could be considered responsibilities. We can combine them under Responsibilities heading as a list.
Let's list responsibilities:
- Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, 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.).
- Manages trial and program projects including team activities (i.e. meetings, document/collaborative workspace management, etc.), provides risk assessment and contingency planning, under accelerated timelines.
- Familiar with early drug development processes, building knowledge and skills to effectively manage additional processes/procedures.
Also earlier duties like coordinating design, planning, execution, overseeing trials, managing team performance, ensuring safety assessment, real-time oversight, reviewing data, on-site monitoring, applying GCP etc. Those could also be responsibilities. But we already have About the role covering many. To avoid duplication, we could put those in About the role and responsibilities as separate list focusing on the later sections. However we need to preserve all substantive information; we shouldn't omit details. So we need to include all duties somewhere. Could put them all under Responsibilities as a comprehensive list, and About the role could be brief summary. But the instruction: "Use
for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Remove boilerplate, navigation, etc.
We need to parse the job posting text.
Key sections:
- About This Role: description of role.
- Responsibilities: bullet points of duties.
- Required Experience And Skills: list of required experience and skills.
- Education Minimum Requirement: education.
- Benefits: there is a Benefits section later: "More Than A Job Benefits Benefits vary by country, but Parexel is passionate about our team’s overall wellness." That's vague; not specific. Also earlier there is "Benefits & Support" with bullet points: Flexible Work Program, Bravo Recognition Program, well-being. That seems specific enough? It says: "Explore the Flexible Work Program, our "Bravo" Recognition Program, and how we build our well-being in our supportive culture." That's somewhat specific but not detailed list. Might still count as Benefits section.
- Pay: not mentioned.
- Schedule: not mentioned (flexible work program mentions flexible arrangement but not schedule specifics). Could include Schedule? Probably not.
We need to include sections only if real specific content.
Let's extract:
About the role: The paragraph after "About This Role": "Parexel FSP has an exciting opportunity for a Clinical Scientist! The Early Clinical Scientist/ECS coordinates the design, planning and execution of early phase clinical trials 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 internal/external team performance to achieve project objectives and resolves project performance issues if they arise. Ensures appropriate clinical safety assessment and risk management of compounds. Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues. Reviews and interprets clinical trial data. May conduct on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes. Applies thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development."
That's substantive.
Responsibilities: Could be the bullet list after "Technical Writing & Communications", "Project Management". Actually the posting includes sections: "Technical Writing & Communications", "Project Management". Those could be considered responsibilities. We can combine them under Responsibilities heading as a list.
Let's list responsibilities:
- Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, 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.).
- Manages trial and program projects including team activities (i.e. meetings, document/collaborative workspace management, etc.), provides risk assessment and contingency planning, under accelerated timelines.
- Familiar with early drug development processes, building knowledge and skills to effectively manage additional processes/procedures.
Also earlier duties like coordinating design, planning, execution, overseeing trials, managing team performance, ensuring safety assessment, real-time oversight, reviewing data, on-site monitoring, applying GCP etc. Those could also be responsibilities. But we already have About the role covering many. To avoid duplication, we could put those in About the role and responsibilities as separate list focusing on the later sections. However we need to preserve all substantive information; we shouldn't omit details. So we need to include all duties somewhere. Could put them all under Responsibilities as a comprehensive list, and About the role could be brief summary. But the instruction: "Use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." So we can have both About the role and Responsibilities sections. We need to avoid repeating same content. We can put a brief overview in About the role, and detailed list in Responsibilities.
Let's craft About the role: a short paragraph summarizing the role: "Parexel FSP has an exciting opportunity for a Clinical Scientist! The Early Clinical Scientist/ECS coordinates the design, planning and execution of early phase clinical trials 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 internal/external team performance to achieve project objectives and resolves project performance issues if they arise. Ensures appropriate clinical safety assessment and risk management of compounds. Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues. Reviews and interprets clinical trial data. May conduct on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes. Applies thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development."
That's fine.
Now Responsibilities: list items from Technical Writing & Communications and Project Management plus maybe other duties not covered? But we already covered many in About the role; to avoid duplication we could still list them but it's okay if some overlap? The instruction: "Preserve ALL substantive information; do NOT invent or summarize away detail." Overlap is not inventing or summarizing away; it's repeating detail, which is okay but maybe not ideal. However we could split: About the role includes overview; Responsibilities includes the specific tasks like authoring documents, managing projects, etc. The earlier duties like coordinating design etc. could be considered part of About the role; we could keep them there and not repeat in Responsibilities. That would preserve all info (they are in About the role). Good.
Thus Responsibilities list:
- Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, 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.).
- Manages trial and program projects including team activities (i.e. meetings, document/collaborative workspace management, etc.), provides risk assessment and contingency planning, under accelerated timelines.
- Familiar with early drug development processes, building knowledge and skills to effectively manage additional processes/procedures.
Now Requirements: The section "Required Experience And Skills" includes a list. We'll put that under Requirements heading as a list.
List items:
- 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 the following: protocol, ICF, IB, CSR, biomarker process, site and medical monitoring plans, risk assessment, protocol deviations
- Working in Microsoft Teams
- Understanding of clinical research development process from program planning to regulatory submission
- Able to quickly develop a 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 (written & verbal), issue identification and resolution skills
- Knowledge of GCP, ICH guidelines and regulatory requirements
Now Qualifications: Education Minimum Requirement. Could be under Qualifications heading.
List:
- 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
- e.g., knowledge of clinical trial management and trial execution; clinical site training/monitoring; medical and regulatory writing; OR equivalent experience with developing preclinical model experiments for drug candidates (protocol authoring, experiment execution/oversight, authoring experiment reports).
We could treat as Qualifications.
Now Benefits: There's a Benefits & Support section: "Explore the Flexible Work Program, our "Bravo" Recognition Program, and how we build our well-being in our supportive culture." Also earlier "More Than A Job Benefits Benefits vary by country, but Parexel is passionate about our team’s overall wellness." That's vague. The specific benefits: Flexible Work Program, Bravo Recognition Program, well-being initiatives. We'll include Benefits section with those items as list.
Pay: not mentioned.
Schedule: not mentioned (flexible work program mentions flexible arrangement but not schedule). Could we infer schedule? Probably not; we should not create Schedule section unless posting actually states them. So omit.
Now we need to output only HTML fragment, no /. Use for headings, - for lists,
for prose.
We need to ensure we don't include boilerplate like EEO disclaimer, navigation, cookie, etc.
Let's craft:
About the role
Parexel FSP has an exciting opportunity for a Clinical Scientist! The Early Clinical Scientist/ECS coordinates the design, planning and execution of early phase clinical trials 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 internal/external team performance to achieve project objectives and resolves project performance issues if they arise. Ensures appropriate clinical safety assessment and risk management of compounds. Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues. Reviews and interprets clinical trial data. May conduct on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes. Applies thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
Responsibilities
- Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, 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.).
- Manages trial and program projects including team activities (i.e. meetings, document/collaborative workspace management, etc.), provides risk assessment and contingency planning, under accelerated timelines.
- Familiar with early drug development processes, building knowledge and skills to effectively manage additional processes/procedures.
Requirements
- 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 the following: protocol, ICF, IB, CSR, biomarker process, site and medical monitoring plans, risk assessment, protocol deviations
- Working in Microsoft Teams
- Understanding of clinical research development process from program planning to regulatory submission
- Able to quickly develop a 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 (written & verbal), issue identification and resolution skills
- Knowledge of GCP, ICH guidelines and regulatory requirements
Qualifications
- 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
- e.g., knowledge of clinical trial management and trial execution; clinical site training/monitoring; medical and regulatory writing; OR equivalent experience with developing preclinical model experiments
for headings, - for lists,
for prose.
We need to ensure we don't include boilerplate like EEO disclaimer, navigation, cookie, etc.
Let's craft:
About the role
Parexel FSP has an exciting opportunity for a Clinical Scientist! The Early Clinical Scientist/ECS coordinates the design, planning and execution of early phase clinical trials 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 internal/external team performance to achieve project objectives and resolves project performance issues if they arise. Ensures appropriate clinical safety assessment and risk management of compounds. Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues. Reviews and interprets clinical trial data. May conduct on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes. Applies thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
Responsibilities
- Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, 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.).
- Manages trial and program projects including team activities (i.e. meetings, document/collaborative workspace management, etc.), provides risk assessment and contingency planning, under accelerated timelines.
- Familiar with early drug development processes, building knowledge and skills to effectively manage additional processes/procedures.
Requirements
- 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 the following: protocol, ICF, IB, CSR, biomarker process, site and medical monitoring plans, risk assessment, protocol deviations
- Working in Microsoft Teams
- Understanding of clinical research development process from program planning to regulatory submission
- Able to quickly develop a 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 (written & verbal), issue identification and resolution skills
- Knowledge of GCP, ICH guidelines and regulatory requirements
Qualifications
- 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
- e.g., knowledge of clinical trial management and trial execution; clinical site training/monitoring; medical and regulatory writing; OR equivalent experience with developing preclinical model experiments
for prose. We need to ensure we don't include boilerplate like EEO disclaimer, navigation, cookie, etc. Let's craft:
About the role
Parexel FSP has an exciting opportunity for a Clinical Scientist! The Early Clinical Scientist/ECS coordinates the design, planning and execution of early phase clinical trials 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 internal/external team performance to achieve project objectives and resolves project performance issues if they arise. Ensures appropriate clinical safety assessment and risk management of compounds. Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues. Reviews and interprets clinical trial data. May conduct on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes. Applies thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
Responsibilities
- Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, 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.).
- Manages trial and program projects including team activities (i.e. meetings, document/collaborative workspace management, etc.), provides risk assessment and contingency planning, under accelerated timelines.
- Familiar with early drug development processes, building knowledge and skills to effectively manage additional processes/procedures.
Requirements
- 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 the following: protocol, ICF, IB, CSR, biomarker process, site and medical monitoring plans, risk assessment, protocol deviations
- Working in Microsoft Teams
- Understanding of clinical research development process from program planning to regulatory submission
- Able to quickly develop a 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 (written & verbal), issue identification and resolution skills
- Knowledge of GCP, ICH guidelines and regulatory requirements
Qualifications
- 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
- e.g., knowledge of clinical trial management and trial execution; clinical site training/monitoring; medical and regulatory writing; OR equivalent experience with developing preclinical model experiments