Temporary - Clinical Trials Manager
Behavioral Health Market Context
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Job Description
entific processes andentrepreneurial philosophies, we are at the forefront of emerginghigh-growth technologies across a wide range of industries.
The Company is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. The Company may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.
Position Summary
The Clinical Trails Manager is responsible for managing the activities of several clinical studies including assisting in the development of study-related documents, study site management, and patient data monitoring. The role will provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
Essential Functions
• Assist in the development and management of company-sponsored clinical trials
• Assist in reviewing completed assignments by members of the clinical development group
• Assist in the development and management of revisions to study-related documents such as the informed consent, laboratory manual, pharmacy manual, case report forms (CRFs) and other study execution tools.
• Provide support in site recruitment, site initiation, site payments and site close-out.
• Help to oversee the training of new clinical site staff or site training for protocol amendments.
• Liaise with the regulatory department for the collection of updated regulatory documents as needed.
• Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
• Assist in the training of clinical development group staff.
• Prepare and update clinical trial updates for Clinical Development team
• Lead/moderate DSMB teleconferences, monthly PI and Study Coordinator teleconferences.
• Provide support for summarizing and maintaining patient treatment, response and survival data for active studies.
• Performs other duties as assigned.
Education & Experience
• Bachelor's degree in biological science with 5+ years of relevant experience in clinical research required
Knowledge, Skills, & Abilities
• Proficiency in MS Word, Excel, PowerPoint, Outlook
• Excellent written/oral communication skills as well as strong organizational and multi-tasking skills.
• Understand the job-specific system and processes as defined by the company's SOPs and adhere to the requirements listed in those documents. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager.
• Maintain corporate confidentiality at all times.
Working Environment / Physical Environment
• This position works on site in El Segundo, CA or remotely depending on the geographic location of the candidate.
• Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval.
• This position will be exposed to an in-lab environment.
• This position may travel approximately 20% of the time.
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
This position is eligible for a discretionary bonus and equity award. The hourly base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.
National Market (all markets unless identified as Premium)
$59.93 (entry-level qualifications) to $66.59 (highly experienced) hourly
Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston)
$62.74 (entry-level qualifications) to $69.71 (highly experienced) hourly
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
This is the pay range the Company reasonably expects to pay for this position at thetime of this posting. Compensation will be determined based on the skills,qualifications, and experience of the applicant along with the requirements of theposition.
NantWorks (the "Company") is the parentcompany of various private and public entities that are changinghow we work, live and play. We focus on three main categories: lifesciences; energy & renewables; and media & technology. We investin strategies that improve our core capabilities and in brandnew industries, poised to change mankind for the better. Bycapturing tomorrow's opportunities through scientific processes andentrepreneurial philosophies, we are at the forefront of emerginghigh-growth technologies across a wide range of industries.
The Company is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. The Company may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.
Position Summary
The Clinical Trails Manager is responsible for managing the activities of several clinical studies including assisting in the development of study-related documents, study site management, and patient data monitoring. The role will provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
Essential Functions
• Assist in the development and management of company-sponsored clinical trials
• Assist in reviewing completed assignments by members of the clinical development group
• Assist in the development and management of revisions to study-related documents such as the informed consent, laboratory manual, pharmacy manual, case report forms (CRFs) and other study execution tools.
• Provide support in site recruitment, site initiation, site payments and site close-out.
• Help to oversee the training of new clinical site staff or site training for protocol amendments.
• Liaise with the regulatory department for the collection of updated regulatory documents as needed.
• Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
• Assist in the training of clinical development group staff.
• Prepare and update clinical trial updates for Clinical Development team
• Lead/moderate DSMB teleconferences, monthly PI and Study Coordinator teleconferences.
• Provide support for summarizing and maintaining patient treatment, response and survival data for active studies.
• Performs other duties as assigned.
Education & Experience
• Bachelor's degree in biological science with 5+ years of relevant experience in clinical research required
Knowledge, Skills, & Abilities
• Proficiency in MS Word, Excel, PowerPoint, Outlook
• Excellent written/oral communication skills as well as strong organizational and multi-tasking skills.
• Understand the job-specific system and processes as defined by the company's SOPs and adhere to the requirements listed in those documents. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager.
• Maintain corporate confidentiality at all times.
Working Environment / Physical Environment
• This position works on site in El Segundo, CA or remotely depending on the geographic location of the candidate.
• Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval.
• This position will be exposed to an in-lab environment.
• This position may travel approximately 20% of the time.
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
This position is eligible for a discretionary bonus and equity award. The hourly base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.
National Market (all markets unless identified as Premium)
$59.93 (entry-level qualifications) to $66.59 (highly experienced) hourly
Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston)
$62.74 (entry-level qualifications) to $69.71 (highly experienced) hourly
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
This is the pay range the Company reasonably expects to pay for this position at thetime of this posting. Compensation will be determined based on the skills,qualifications, and experience of the applicant along with the requirements of theposition.
The Company is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. The Company may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.
Position Summary
The Clinical Trails Manager is responsible for managing the activities of several clinical studies including assisting in the development of study-related documents, study site management, and patient data monitoring. The role will provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
Essential Functions
• Assist in the development and management of company-sponsored clinical trials
• Assist in reviewing completed assignments by members of the clinical development group
• Assist in the development and management of revisions to study-related documents such as the informed consent, laboratory manual, pharmacy manual, case report forms (CRFs) and other study execution tools.
• Provide support in site recruitment, site initiation, site payments and site close-out.
• Help to oversee the training of new clinical site staff or site training for protocol amendments.
• Liaise with the regulatory department for the collection of updated regulatory documents as needed.
• Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
• Assist in the training of clinical development group staff.
• Prepare and update clinical trial updates for Clinical Development team
• Lead/moderate DSMB teleconferences, monthly PI and Study Coordinator teleconferences.
• Provide support for summarizing and maintaining patient treatment, response and survival data for active studies.
• Performs other duties as assigned.
Education & Experience
• Bachelor's degree in biological science with 5+ years of relevant experience in clinical research required
Knowledge, Skills, & Abilities
• Proficiency in MS Word, Excel, PowerPoint, Outlook
• Excellent written/oral communication skills as well as strong organizational and multi-tasking skills.
• Understand the job-specific system and processes as defined by the company's SOPs and adhere to the requirements listed in those documents. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager.
• Maintain corporate confidentiality at all times.
Working Environment / Physical Environment
• This position works on site in El Segundo, CA or remotely depending on the geographic location of the candidate.
• Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval.
• This position will be exposed to an in-lab environment.
• This position may travel approximately 20% of the time.
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
This position is eligible for a discretionary bonus and equity award. The hourly base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.
National Market (all markets unless identified as Premium)
$59.93 (entry-level qualifications) to $66.59 (highly experienced) hourly
Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston)
$62.74 (entry-level qualifications) to $69.71 (highly experienced) hourly
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
This is the pay range the Company reasonably expects to pay for this position at thetime of this posting. Compensation will be determined based on the skills,qualifications, and experience of the applicant along with the requirements of theposition.
NantWorks (the "Company") is the parentcompany of various private and public entities that are changinghow we work, live and play. We focus on three main categories: lifesciences; energy & renewables; and media & technology. We investin strategies that improve our core capabilities and in brandnew industries, poised to change mankind for the better. Bycapturing tomorrow's opportunities through scientific processes andentrepreneurial philosophies, we are at the forefront of emerginghigh-growth technologies across a wide range of industries.
The Company is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. The Company may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.
Position Summary
The Clinical Trails Manager is responsible for managing the activities of several clinical studies including assisting in the development of study-related documents, study site management, and patient data monitoring. The role will provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
Essential Functions
• Assist in the development and management of company-sponsored clinical trials
• Assist in reviewing completed assignments by members of the clinical development group
• Assist in the development and management of revisions to study-related documents such as the informed consent, laboratory manual, pharmacy manual, case report forms (CRFs) and other study execution tools.
• Provide support in site recruitment, site initiation, site payments and site close-out.
• Help to oversee the training of new clinical site staff or site training for protocol amendments.
• Liaise with the regulatory department for the collection of updated regulatory documents as needed.
• Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
• Assist in the training of clinical development group staff.
• Prepare and update clinical trial updates for Clinical Development team
• Lead/moderate DSMB teleconferences, monthly PI and Study Coordinator teleconferences.
• Provide support for summarizing and maintaining patient treatment, response and survival data for active studies.
• Performs other duties as assigned.
Education & Experience
• Bachelor's degree in biological science with 5+ years of relevant experience in clinical research required
Knowledge, Skills, & Abilities
• Proficiency in MS Word, Excel, PowerPoint, Outlook
• Excellent written/oral communication skills as well as strong organizational and multi-tasking skills.
• Understand the job-specific system and processes as defined by the company's SOPs and adhere to the requirements listed in those documents. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager.
• Maintain corporate confidentiality at all times.
Working Environment / Physical Environment
• This position works on site in El Segundo, CA or remotely depending on the geographic location of the candidate.
• Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval.
• This position will be exposed to an in-lab environment.
• This position may travel approximately 20% of the time.
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
This position is eligible for a discretionary bonus and equity award. The hourly base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.
National Market (all markets unless identified as Premium)
$59.93 (entry-level qualifications) to $66.59 (highly experienced) hourly
Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston)
$62.74 (entry-level qualifications) to $69.71 (highly experienced) hourly
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
This is the pay range the Company reasonably expects to pay for this position at thetime of this posting. Compensation will be determined based on the skills,qualifications, and experience of the applicant along with the requirements of theposition.
Qualifications
- •Bachelor's degree in biological science with 5+ years of relevant experience in clinical research required
- •Proficiency in MS Word, Excel, PowerPoint, Outlook
- •Excellent written/oral communication skills as well as strong organizational and multi-tasking skills
- •Understand the job-specific system and processes as defined by the company's SOPs and adhere to the requirements listed in those documents
- •Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer
- •Proof of vaccination will be required prior to start
- •Bachelor's degree in biological science with 5+ years of relevant experience in clinical research required
- •Proficiency in MS Word, Excel, PowerPoint, Outlook
- •Excellent written/oral communication skills as well as strong organizational and multi-tasking skills
- •Understand the job-specific system and processes as defined by the company's SOPs and adhere to the requirements listed in those documents
- •Flexibility is available with manager approval
- •This position will be exposed to an in-lab environment
- •Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer
Benefits
- •This position is eligible for a discretionary bonus and equity award
- •The hourly base pay range for this position is below
- •$59.93 (entry-level qualifications) to $66.59 (highly experienced) hourly
- •$62.74 (entry-level qualifications) to $69.71 (highly experienced) hourly
- •This position is eligible for a discretionary bonus and equity award
- •The hourly base pay range for this position is below
- •$59.93 (entry-level qualifications) to $66.59 (highly experienced) hourly
- •$62.74 (entry-level qualifications) to $69.71 (highly experienced) hourly
Responsibilities
- •If you require a medical or religious accommodation we will engage in the interactive process with you
- •Proof of vaccination will be required prior to start
- •The Clinical Trails Manager is responsible for managing the activities of several clinical studies including assisting in the development of study-related documents, study site management, and patient data monitoring
- •The role will provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance
- •Assist in the development and management of company-sponsored clinical trials
- •Assist in reviewing completed assignments by members of the clinical development group
- •Assist in the development and management of revisions to study-related documents such as the informed consent, laboratory manual, pharmacy manual, case report forms (CRFs) and other study execution tools
- •Provide support in site recruitment, site initiation, site payments and site close-out
- •Help to oversee the training of new clinical site staff or site training for protocol amendments
- •Liaise with the regulatory department for the collection of updated regulatory documents as needed
- •Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance
- •Assist in the training of clinical development group staff
- •Prepare and update clinical trial updates for Clinical Development team
- •Lead/moderate DSMB teleconferences, monthly PI and Study Coordinator teleconferences
- •Provide support for summarizing and maintaining patient treatment, response and survival data for active studies
- •Performs other duties as assigned
- •If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager
- •Maintain corporate confidentiality at all times
- •This position works on site in El Segundo, CA or remotely depending on the geographic location of the candidate
- •Regular work schedule is Monday - Friday, within standard business hours
- •Flexibility is available with manager approval
- •This position will be exposed to an in-lab environment
- •This position may travel approximately 20% of the time
- •If you require a medical or religious accommodation we will engage in the interactive process with you
- •The Clinical Trails Manager is responsible for managing the activities of several clinical studies including assisting in the development of study-related documents, study site management, and patient data monitoring
- •The role will provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance
- •Assist in the development and management of company-sponsored clinical trials
- •Assist in reviewing completed assignments by members of the clinical development group
- •Assist in the development and management of revisions to study-related documents such as the informed consent, laboratory manual, pharmacy manual, case report forms (CRFs) and other study execution tools
- •Provide support in site recruitment, site initiation, site payments and site close-out
- •Help to oversee the training of new clinical site staff or site training for protocol amendments
- •Liaise with the regulatory department for the collection of updated regulatory documents as needed
- •Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance
- •Assist in the training of clinical development group staff
- •Prepare and update clinical trial updates for Clinical Development team
- •Lead/moderate DSMB teleconferences, monthly PI and Study Coordinator teleconferences
- •Provide support for summarizing and maintaining patient treatment, response and survival data for active studies
- •Performs other duties as assigned
- •If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager
- •Maintain corporate confidentiality at all times
- •Regular work schedule is Monday - Friday, within standard business hours
- •This position may travel approximately 20% of the time
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