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Associate Director Clinical Quality Manager

Job Description

Location:

  • New Providence, NJ

Summary:

The Associate Director, Clinical Quality Management provides GCP and GPVP advisement and proactive support to clinical study teams during clinical trial planning and start-up and partners with key leaders to support quality oversight and management of clinical studies during conduct. The individual in this position manages execution of the annual GCP/PV Audit Program and GCP/PV training. This position leads inspection readiness of clinical teams for FDA, EU and key HA pre-approval and sponsor-monitor inspections and provides inspection management support and follow-up.

Requirements:

  • Bachelor's degree in biological sciences or similar field.
  • Minimum of 8 years of experience in the biopharmaceutical industry or other relevant clinical research experience, contributing to management/auditing/monitoring of multinational clinical trials.
  • Strong knowledge of ICH Good Clinical Practices and relevant regulations and guidelines.
  • Experience with interacting with inspectors and cross-functional, global teams.





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-NJ-New Providence
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Biotech, Pharmaceutical
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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-NJ-New Providence
Gabriella Miele
9738294439
Snapshot
Aerotek
Company:
US-NJ-New Providence
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Biotech, Pharmaceutical
Store Type:

Job Description

Location:

  • New Providence, NJ

Summary:

The Associate Director, Clinical Quality Management provides GCP and GPVP advisement and proactive support to clinical study teams during clinical trial planning and start-up and partners with key leaders to support quality oversight and management of clinical studies during conduct. The individual in this position manages execution of the annual GCP/PV Audit Program and GCP/PV training. This position leads inspection readiness of clinical teams for FDA, EU and key HA pre-approval and sponsor-monitor inspections and provides inspection management support and follow-up.

Requirements:

  • Bachelor's degree in biological sciences or similar field.
  • Minimum of 8 years of experience in the biopharmaceutical industry or other relevant clinical research experience, contributing to management/auditing/monitoring of multinational clinical trials.
  • Strong knowledge of ICH Good Clinical Practices and relevant regulations and guidelines.
  • Experience with interacting with inspectors and cross-functional, global teams.





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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Associate Director Clinical Quality Manager Apply now