The Clinical Study Manager must be able to work independently on multiple complex clinical studies using critical thinking skills. This position may be part of a small, cross functional team or may ...

60 Advanced Clinical Clinical Study Manager Jobs Hiring Near You
The Clinical Study Manager must be able to work independently on multiple complex clinical studies using critical thinking skills. This position may be part of a small, cross functional team or may ...
Associate Clinical Study Manager (San Antonio, Tx)
San Antonio, TX · On-site
$19.95 - $39.66/hr
What the Associate Clinical Study Manager does at Worldwide The Associate, Clinical Study Manager will be responsible for the site-level monitoring activities of on one or more allocated Phase I ...
Associate Clinical Study Manager (San Antonio, Tx)
San Antonio, TX · On-site
$19.95 - $39.66/hr
What the Associate Clinical Study Manager does at Worldwide The Associate, Clinical Study Manager will be responsible for the site-level monitoring activities of on one or more allocated Phase I ...
Senior Clinical Study Manager (Hybrid)
Mahwah, NJ · Hybrid
$132K - $220K/yr
As Senior Clinical Study Manager, you will serve as the cross-functional project leader responsible for delivering clinical research business initiatives through effective project execution ...
Senior Clinical Study Manager (Hybrid)
Mahwah, NJ · Hybrid
$132K - $220K/yr
As Senior Clinical Study Manager, you will serve as the cross-functional project leader responsible for delivering clinical research business initiatives through effective project execution ...
Manager Study Start-up
San Clemente, CA · On-site
Clinical Study Manager The Clinical Study Manager is responsible for the end-to-end management and execution of clinical studies supporting medical device development. This role leads cross ...
Manager Study Start-up
San Clemente, CA · On-site
Clinical Study Manager The Clinical Study Manager is responsible for the end-to-end management and execution of clinical studies supporting medical device development. This role leads cross ...
Good project management and time management skills. Ability to be a self-starter and work cooperatively with others in a small-company environment. Ability to treat at clinical study participants ...
Good project management and time management skills. Ability to be a self-starter and work cooperatively with others in a small-company environment. Ability to treat at clinical study participants ...
Good project management and time management skills. Ability to be a self-starter and work cooperatively with others in a small-company environment. Ability to treat at clinical study participants ...
Good project management and time management skills. Ability to be a self-starter and work cooperatively with others in a small-company environment. Ability to treat at clinical study participants ...
Senior Manager, Clinical Studies
Minneapolis, MN · On-site
$140K - $180K/yr
The Clinical Study Manager must be able to work independently on multiple complex clinical studies using critical thinking skills. This position may be part of a small, cross functional team or may ...
Senior Manager, Clinical Studies
Minneapolis, MN · On-site
$140K - $180K/yr
The Clinical Study Manager must be able to work independently on multiple complex clinical studies using critical thinking skills. This position may be part of a small, cross functional team or may ...
Clinical Study Recruiter
Austin, TX · On-site
$14/hr
Good project management and time management skills. Ability to be a self-starter and work cooperatively with others in a small-company environment. Ability to treat at clinical study participants ...
Clinical Study Recruiter
Austin, TX · On-site
$14/hr
Good project management and time management skills. Ability to be a self-starter and work cooperatively with others in a small-company environment. Ability to treat at clinical study participants ...
Clinical Research Study Manager The Study Manager is responsible to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations ...
Clinical Research Study Manager The Study Manager is responsible to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations ...
Clinical Research Study Manager A Study Manager is responsible to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations ...
Clinical Research Study Manager A Study Manager is responsible to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations ...
Manager Clinical Study Lead
Warren, NJ · On-site
Manager, Clinical Study Lead Build our future together: The Manager, Clinical Study Lead may perform the following responsibilities with moderate oversight: accountable for the global execution of ...
New
Manager Clinical Study Lead
Warren, NJ · On-site
Manager, Clinical Study Lead Build our future together: The Manager, Clinical Study Lead may perform the following responsibilities with moderate oversight: accountable for the global execution of ...
New
$150 - $200/hr
Timelines, Planning and Execution Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines
$150 - $200/hr
Timelines, Planning and Execution Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines
Manager Clinical Study Lead
Armonk, NY · On-site
The Manager, Clinical Study Lead may perform the following responsibilities with moderate oversight: accountable for the global execution of assigned smaller or less complex clinical trials from ...
Manager Clinical Study Lead
Armonk, NY · On-site
The Manager, Clinical Study Lead may perform the following responsibilities with moderate oversight: accountable for the global execution of assigned smaller or less complex clinical trials from ...
The Manager, Clinical Study Lead may perform the following responsibilities with moderate oversight: accountable for the global execution of assigned smaller or less complex clinical trials from ...
The Manager, Clinical Study Lead may perform the following responsibilities with moderate oversight: accountable for the global execution of assigned smaller or less complex clinical trials from ...
Manager Clinical Study Lead
Warren, MI · On-site
The Manager, Clinical Study Lead may perform the following responsibilities with moderate oversight: accountable for the global execution of assigned smaller or less complex clinical trials from ...
Manager Clinical Study Lead
Warren, MI · On-site
The Manager, Clinical Study Lead may perform the following responsibilities with moderate oversight: accountable for the global execution of assigned smaller or less complex clinical trials from ...
Manager Clinical Study Lead
Armonk, NY · On-site
$150 - $200/hr
The Manager, Clinical Study Lead may perform the following responsibilities with moderate oversight: accountable for the global execution of assigned smaller or less complex clinical trials from ...
Manager Clinical Study Lead
Armonk, NY · On-site
$150 - $200/hr
The Manager, Clinical Study Lead may perform the following responsibilities with moderate oversight: accountable for the global execution of assigned smaller or less complex clinical trials from ...
The Senior Study Manager (SSM) is responsible for ensuring clinical study quality and consistency of performance, and in conjunction within Clinical Operations and with all other teams/departments is ...
The Senior Study Manager (SSM) is responsible for ensuring clinical study quality and consistency of performance, and in conjunction within Clinical Operations and with all other teams/departments is ...
Study Manager I
Phoenix, AZ · On-site
$100 - $125/hr
A Study Manager is responsible to ensure that quality research is conducted at assigned ... Working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator ...
Study Manager I
Phoenix, AZ · On-site
$100 - $125/hr
A Study Manager is responsible to ensure that quality research is conducted at assigned ... Working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator ...
Clinical Study Specialist
Cambridge, MA · On-site
$60 - $80/hr
Manage and maintain team SharePoint sites and/or shared drives as needed. * Communicate with ... advanced degree in a related field with 1-2 years of relevant experience preferred. * Strong ...
Clinical Study Specialist
Cambridge, MA · On-site
$60 - $80/hr
Manage and maintain team SharePoint sites and/or shared drives as needed. * Communicate with ... advanced degree in a related field with 1-2 years of relevant experience preferred. * Strong ...
Advanced technical proficiency in trial management systems and MS applications including (but not ... clinical studies Does this sound like you? Apply now to take your first step towards living the ...
Advanced technical proficiency in trial management systems and MS applications including (but not ... clinical studies Does this sound like you? Apply now to take your first step towards living the ...
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Full-time
Re-posted 4 days ago
Job description
POSITION SUMMARY
This position is for overseeing clinical activities related to one or more clinical studies and performing/managing the daily in-house operations associated with the studies. The Clinical Study Manager must be able to work independently on multiple complex clinical studies using critical thinking skills. This position may be part of a small, cross functional team or may have direct reports.
MAIN DUTIES/RESPONSIBILITIES
- Responsible for managing clinical studies in accordance with internal standard operating procedures and applicable regulations and guidelines
- Collaborate with internal and external clinical team members, consultants and/or CROs to draft clinical study protocols and other clinical study documentation
- Oversee clinical site selection and activation
- Manage study safety by tracking and reporting adverse events as required by regulatory bodies, reviewing adverse event trends, and overseeing safety committees including Clinical Events Committees and Data Safety Monitoring Boards
- Oversee monitoring activities related to assigned clinical studies including review and approval of monitoring plan and monitoring reports, managing monitoring schedule and ensuring corrective action related to monitoring findings
- Develop training plans for study training and review/approve training documentation
- Prepare study-related reports including annual, interim and final study reports
- Organize and lead study-related conference calls and Investigator meetings as needed through the study
- Oversee investigational device allocation, distribution and reconciliation
- Collaborate with data management team and/or CRO to ensure appropriate data capture, query management and to identify data analysis needs
- Use critical thinking skills to review and analyze scientific journal articles
- Assist with generation and/or review of study-related abstracts, posters, presentations, manuscripts as needed
QUALITY SYSTEM RESPONSIBILITIES
- Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
- Complete training requirements and competency confirmations as required for this position within the required timeline.
- Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.
- Ensure all direct reports maintain training records that comply with applicable quality system requirements. (if applicable)
QUALIFICATIONS
Educational Requirements:
- Required: Bachelor's Degree required
- Preferred: Science Degree preferred (Biology, Chemistry, etc.)
Required Experience:
- Previous clinical research experience (minimum 5 years) required
- Previous clinical study management experience preferred
- International clinical experience preferred
- Previous collaboration with physician investigators
- Strong knowledge of clinical research study design and study monitoring functions
- Understanding of GCP and 21 CFR 812
- Experience working with Institutional Review Boards and/or Ethics Committees
- Strong technical writing skills
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About Inspire Medical Systems
Sourced by ZipRecruiter
Industry
Outpatient health care
Company size
201 - 500 Employees
Headquarters location
Golden Valley, MN, US
Year founded
2007