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Clinical Project Manager

Job Description

One of our growing CRO clients is currently looking for an additional Clinical Project Manager who will be a critical team member reporting directly to the Director of Clinical Affairs, to support clinical trial operations for the firm's clientele. Primary responsibilities will include providing oversight and management for all clinical aspects of the development and execution of clinical trials/protocols. The CPM will execute Clinical Affairs functions in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.

* Ensure that clinical studies are properly resourced, managed and executed in accordance with established timelines and quality standards.
* Ensure that studies are conducted according to the study protocol, SOPs, ICH/GCP regulations and study-specific manuals and procedures.
* Develop and maintain positive relationships both internal and external to project, including clients, team members, and site personnel (PIs, Study coordinators, etc.)
* Lead and direct project team to ensure deliverables meet project timelines.
* Track and report on progress of study including site activation, patient enrollment, and monitoring visits.
* Develop Clinical Monitoring Plan and other project documents as assigned.
* Manage clinical monitoring functions of clinical studies.
* Approve reports and study communications generated by the project team for distribution to sponsors and investigators.
* Ensure Trial Master File is accurate and complete throughout the lifecycle of the project.
* Assist with professional development for Clinical Research Associates and Clinical Associates.
* Maintain knowledge of current GCP, FDA, and other applicable regulations.
* Other duties as assigned by Senior Director, Clinical Affairs
* Assist with site audits activities as needed.
* Maintain current knowledge of GCP and FDA guidance as it relates to clinical research, as well as current clinical related developments in the assigned therapeutic areas.




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.



The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 

Job Snapshot

Location US-DC-Washington
Employment Type Full-Time
Pay Type Year
Pay Rate $999,999.00 /Year
Store Type Biotech, Research
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Company Overview

Aerotek

We know that a company’s success starts with its employees. We also know that an individual’s success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek’s people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has become a leader in recruiting and staffing services by building quality relationships that allow us to place quality people in quality jobs. With more than 230 non-franchised offices, Aerotek’s 6,000 internal employees serve more than 300,000 contract employees and 17,000 clients every year. To learn more, visit Aerotek.com. Learn More

Contact Information

US-DC-Washington
Nathalie Karam
3012504323
Snapshot
Aerotek
Company:
US-DC-Washington
Location:
Full-Time
Employment Type:
Year
Pay Type:
$999,999.00 /Year
Pay Rate:
Biotech, Research
Store Type:

Job Description

One of our growing CRO clients is currently looking for an additional Clinical Project Manager who will be a critical team member reporting directly to the Director of Clinical Affairs, to support clinical trial operations for the firm's clientele. Primary responsibilities will include providing oversight and management for all clinical aspects of the development and execution of clinical trials/protocols. The CPM will execute Clinical Affairs functions in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.

* Ensure that clinical studies are properly resourced, managed and executed in accordance with established timelines and quality standards.
* Ensure that studies are conducted according to the study protocol, SOPs, ICH/GCP regulations and study-specific manuals and procedures.
* Develop and maintain positive relationships both internal and external to project, including clients, team members, and site personnel (PIs, Study coordinators, etc.)
* Lead and direct project team to ensure deliverables meet project timelines.
* Track and report on progress of study including site activation, patient enrollment, and monitoring visits.
* Develop Clinical Monitoring Plan and other project documents as assigned.
* Manage clinical monitoring functions of clinical studies.
* Approve reports and study communications generated by the project team for distribution to sponsors and investigators.
* Ensure Trial Master File is accurate and complete throughout the lifecycle of the project.
* Assist with professional development for Clinical Research Associates and Clinical Associates.
* Maintain knowledge of current GCP, FDA, and other applicable regulations.
* Other duties as assigned by Senior Director, Clinical Affairs
* Assist with site audits activities as needed.
* Maintain current knowledge of GCP and FDA guidance as it relates to clinical research, as well as current clinical related developments in the assigned therapeutic areas.




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.



The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 
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Clinical Project Manager Apply now