Senior Scientist, Clinical Research
About the position
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. Represents Early-Stage Development on cross-functional teams to develop and/or improve internal job aids/SOP/clinical development procedures. Identifies and communicates best practices within the organization. Promotes departmental adaptation of new procedures. Technical Writing & Communications Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections, and regulatory agency update and safety reports, as well as clinical development plans, publications, and abstracts. 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.). Project Management 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.
Responsibilities
• 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.
• Represents Early-Stage Development on cross-functional teams to develop and/or improve internal job aids/SOP/clinical development procedures.
• Identifies and communicates best practices within the organization.
• Promotes departmental adaptation of new procedures.
• Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections, and regulatory agency update and safety reports, as well as clinical development plans, publications, and abstracts.
• 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
• 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
Nice-to-haves
• Global Phase I subject and patient trials, safety reporting, and regulatory WMA submission experience a plus.
• Experience managing Immunology trials with an ability to think outside of the box, explore novel ways of working and comfortably navigate ambiguity to drive results also a plus.
Benefits
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits
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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. Represents Early-Stage Development on cross-functional teams to develop and/or improve internal job aids/SOP/clinical development procedures. Identifies and communicates best practices within the organization. Promotes departmental adaptation of new procedures. Technical Writing & Communications Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections, and regulatory agency update and safety reports, as well as clinical development plans, publications, and abstracts. 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.). Project Management 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.
Responsibilities
• 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.
• Represents Early-Stage Development on cross-functional teams to develop and/or improve internal job aids/SOP/clinical development procedures.
• Identifies and communicates best practices within the organization.
• Promotes departmental adaptation of new procedures.
• Co-authors clinical sections of protocols, clinical investigator brochures, clinical study reports, Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections, and regulatory agency update and safety reports, as well as clinical development plans, publications, and abstracts.
• 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
• 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
Nice-to-haves
• Global Phase I subject and patient trials, safety reporting, and regulatory WMA submission experience a plus.
• Experience managing Immunology trials with an ability to think outside of the box, explore novel ways of working and comfortably navigate ambiguity to drive results also a plus.
Benefits
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits
Apply tot his job
Apply To this Job