Job Summary of the Clinical Study Manager The Clinical Study Manager (CSM) is accountable for the endtoend operational leadership of an Axogensponsored randomized controlled trial (RCT) and other ...
Job Summary of the Clinical Study Manager The Clinical Study Manager (CSM) is accountable for the endtoend operational leadership of an Axogensponsored randomized controlled trial (RCT) and other ...
$57/hr
Qualifications Clinical Study Manager needs 5 years relevant experience is required with a BSc, 3 years with a MS/MPH, or 2 years with PharmD/PhD/MD Clinical Study Manager requires: * Phase II/III ...
$57/hr
Qualifications Clinical Study Manager needs 5 years relevant experience is required with a BSc, 3 years with a MS/MPH, or 2 years with PharmD/PhD/MD Clinical Study Manager requires: * Phase II/III ...
Job Summary of the Clinical Study Manager The Clinical Study Manager (CSM) is accountable for the end‑to‑end operational leadership of an Axogen‑sponsored randomized controlled trial (RCT) and ...
Quick apply
Job Summary of the Clinical Study Manager The Clinical Study Manager (CSM) is accountable for the end‑to‑end operational leadership of an Axogen‑sponsored randomized controlled trial (RCT) and ...
Clinical Study Manager
Tampa, FL · On-site
Job Summary of the Clinical Study Manager The Clinical Study Manager (CSM) is accountable for the end-to-end operational leadership of an Axogen-sponsored randomized controlled trial (RCT) and other ...
Clinical Study Manager
Tampa, FL · On-site
Job Summary of the Clinical Study Manager The Clinical Study Manager (CSM) is accountable for the end-to-end operational leadership of an Axogen-sponsored randomized controlled trial (RCT) and other ...
Clinical Study Manager
Houston, TX · On-site
The Clinical Study Manager is an integral part of the Clinical Operations Team which manages planned and ongoing clinical studies. The Clinical Study Manager is responsible for overseeing the ...
Clinical Study Manager
Houston, TX · On-site
The Clinical Study Manager is an integral part of the Clinical Operations Team which manages planned and ongoing clinical studies. The Clinical Study Manager is responsible for overseeing the ...
Senior Clinical Study Manager
Sunnyvale, CA · On-site +1
This Lead Clinical Study Manager-4 (CSM IV) / Senior Clinical Study Manager role will develop and execute strategies for US and global first-human-use and pivotal pre-market clinical trials to help ...
Senior Clinical Study Manager
Sunnyvale, CA · On-site +1
This Lead Clinical Study Manager-4 (CSM IV) / Senior Clinical Study Manager role will develop and execute strategies for US and global first-human-use and pivotal pre-market clinical trials to help ...
Clinical Study Manager
Naples, FL · On-site
Clinical Study Manager Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Clinical ...
Clinical Study Manager
Naples, FL · On-site
Clinical Study Manager Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Clinical ...
Clinical Study Manager
Houston, TX · On-site
The Clinical Study Manager is an integral part of the Clinical Operations Team which manages planned and ongoing clinical studies. The Clinical Study Manager is responsible for overseeing the ...
Clinical Study Manager
Houston, TX · On-site
The Clinical Study Manager is an integral part of the Clinical Operations Team which manages planned and ongoing clinical studies. The Clinical Study Manager is responsible for overseeing the ...
Clinical Study Manager
Naples, FL · On-site
Clinical Study Manager Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Clinical ...
Clinical Study Manager
Naples, FL · On-site
Clinical Study Manager Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Clinical ...
Senior Clinical Study Manager
Sunnyvale, CA · On-site
This Lead Clinical Study Manager-4 (CSM IV) / Senior Clinical Study Manager role will develop and execute strategies for US and global first-human-use and pivotal pre-market clinical trials to help ...
Senior Clinical Study Manager
Sunnyvale, CA · On-site
This Lead Clinical Study Manager-4 (CSM IV) / Senior Clinical Study Manager role will develop and execute strategies for US and global first-human-use and pivotal pre-market clinical trials to help ...
Senior Clinical Study Manager
San Jose, CA · On-site
$125K - $179K/yr
The Senior Clinical Study Manager is responsible for planning, executing, and overseeing clinical trials to ensure they are conducted efficiently, ethically, and in compliance with regulatory ...
Senior Clinical Study Manager
San Jose, CA · On-site
$125K - $179K/yr
The Senior Clinical Study Manager is responsible for planning, executing, and overseeing clinical trials to ensure they are conducted efficiently, ethically, and in compliance with regulatory ...
Clinical Study Manager
Fridley, MN · On-site
$110K - $160K/yr
About the role The Clinical Study Manager is a key member of the Clinical Affairs team, responsible for leading the operational execution and management of clinical studies that support the company ...
Clinical Study Manager
Fridley, MN · On-site
$110K - $160K/yr
About the role The Clinical Study Manager is a key member of the Clinical Affairs team, responsible for leading the operational execution and management of clinical studies that support the company ...
Senior Clinical Study Manager
Sunnyvale, CA · On-site +1
This Lead Clinical Study Manager-4 (CSM IV) / Senior Clinical Study Manager role will develop and execute strategies for US and global first-human-use and pivotal pre-market clinical trials to help ...
Senior Clinical Study Manager
Sunnyvale, CA · On-site +1
This Lead Clinical Study Manager-4 (CSM IV) / Senior Clinical Study Manager role will develop and execute strategies for US and global first-human-use and pivotal pre-market clinical trials to help ...
Clinical Study Manager
Aliso Viejo, CA · On-site
Summary: The Clinical Study Manager (CSM) plays a key role in the planning and execution of SpyGlass Pharmas clinical trials. Working closely with the Director of Clinical Research and cross ...
Quick apply
Clinical Study Manager
Aliso Viejo, CA · On-site
Summary: The Clinical Study Manager (CSM) plays a key role in the planning and execution of SpyGlass Pharmas clinical trials. Working closely with the Director of Clinical Research and cross ...
Clinical Study Manager
Aliso Viejo, CA · On-site
$140K - $160K/yr
Summary: The Clinical Study Manager (CSM) plays a key role in the planning and execution of SpyGlass Pharma's clinical trials. Working closely with the Director of Clinical Research and cross ...
Clinical Study Manager
Aliso Viejo, CA · On-site
$140K - $160K/yr
Summary: The Clinical Study Manager (CSM) plays a key role in the planning and execution of SpyGlass Pharma's clinical trials. Working closely with the Director of Clinical Research and cross ...
Summary: The Clinical Study Manager (CSM) plays a key role in the planning and execution of SpyGlass Pharma's clinical trials. Working closely with the Director of Clinical Research and cross ...
Summary: The Clinical Study Manager (CSM) plays a key role in the planning and execution of SpyGlass Pharma's clinical trials. Working closely with the Director of Clinical Research and cross ...
General Summary The Clinical Study Manager provides leadership in the planning, design, and execution of clinical studies sponsored by Penumbra to assess safety and effectiveness of products. This ...
General Summary The Clinical Study Manager provides leadership in the planning, design, and execution of clinical studies sponsored by Penumbra to assess safety and effectiveness of products. This ...
Senior Clinical Study Manager
OR · On-site +1
The Senior Clinical Study Manager will be responsible for clinical trial execution within the US for Danaher Diagnostics. This role will specifically support Radiometer Medical, an operating company ...
Senior Clinical Study Manager
OR · On-site +1
The Senior Clinical Study Manager will be responsible for clinical trial execution within the US for Danaher Diagnostics. This role will specifically support Radiometer Medical, an operating company ...
The Associate Director, Clinical Study Management, will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. This role will require a ...
The Associate Director, Clinical Study Management, will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. This role will require a ...
The Associate Director, Clinical Study Management, will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. This role will require a ...
The Associate Director, Clinical Study Management, will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. This role will require a ...
Clinical Study Manager information
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$28.85 - $34.97
4% of jobs
$34.97 - $41.08
6% of jobs
$41.08 - $47.20
7% of jobs
$51.79 is the 25th percentile. Wages below this are outliers.
$47.20 - $53.32
9% of jobs
$53.32 - $59.44
15% of jobs
The median wage is $62.14 / hr.
$59.44 - $65.56
18% of jobs
$69.92 is the 75th percentile. Wages above this are outliers.
$65.56 - $71.68
21% of jobs
$71.68 - $77.80
7% of jobs
$77.80 - $83.92
6% of jobs
$83.92 - $90.03
3% of jobs
$90.03 - $96.15
2% of jobs
$28
$62
$96
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Job description
Job Summary of the Clinical Study Manager
The Clinical Study Manager (CSM) is accountable for the endtoend operational leadership of an Axogensponsored randomized controlled trial (RCT) and other complex prospective clinical studies conducted in highly regulated environments, including biologics, combination products, and medical devices. This role is intended for a highly experienced clinical operations professional who can independently own study execution, serve as the operational authority for an assigned trial, and act as a role model for CRAs, vendors, and crossfunctional partners. The CSM is responsible for ensuring exceptional execution quality, data integrity, and inspection readiness while maintaining the highest standards of ethics and Good Clinical Practice (GCP).Â
Requirements of the Clinical Study Manager
- Bachelor's degree or higher in a scientific, medical, or engineering discipline (or equivalent experience).
- Minimum 5 years of industrysponsored clinical research experience.
- Demonstrated experience leading complex prospective interventional studies, with RCT experience strongly preferred.
- Experience conducting studies in biologics, combination products, and/or medical devices.
- Proven track record of maintaining high data integrity, compliance, and inspection readiness.
- Strong working knowledge of ICHGCP and global regulatory requirements.
- Willingness and ability to travel up to 50%.
Responsibilities of the Clinical Study Manager
The specific duties of the Clinical Study Manager include but are not limited to:
Clinical Operations Leadership
- Lead the planning, start-up, execution, monitoring, and close out of large, complex prospective clinical studies, including RCTs.
- Serve as the study level operational owner, accountable for timelines, quality, compliance, and execution excellence.
- Translate protocol intent and regulatory requirements into robust, executable clinical operations strategies.
Study Planning & Execution
- Develop and execute comprehensive:
- Clinical Operations Plans
- Monitoring Plans
- Vendor Oversight Plans
- Recruitment and retention strategies
- Study timelines, budgets, and resourcing plans
- Ensure study conduct aligns with protocol, SAP, investigational plan, and regulatory commitments.
Quality, Compliance, and Inspection Readiness
- Ensure continuous compliance with:
- ICHGCP
- FDA and OUS regulatory requirements
- Internal SOPs and quality standards
- Proactively identify and mitigate risks to subject safety, data integrity, and regulatory compliance.
- Lead and support audit and inspection readiness, responses, and CAPA development.
Vendor & Site Oversight
- Lead selection, onboarding, and oversight of CROs and other clinical vendors.
- Drive vendor performance through KPIs, issue escalation, and corrective actions.
- Oversee site selection, activation, and ongoing performance, including the performance of on-site visits, enrollment tracking, monitoring quality, protocol adherence.
Team Leadership & Mentorship
- Provide leadership, mentoring, and professional guidance to CRAs and study team members.
- Serve as a role model for bestinclass clinical operations conduct, documentation quality, and ethical decision
- Contribute to SOPs, work instructions, templates, and training materials.
Location
111 West Oak Ave., Tampa, FLÂ 33602
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Benefits/Compensation
About Axogen
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
201 - 500 Employees
Headquarters location
Alachua, FL, US
Year founded
2002