Clinical Research Manager -Quality & Regulatory
Job Title: Clinical Research Manager - Quality & Regulatory
Job Description
We are seeking a skilled and experienced Clinical Research Manager for the Quality & Regulatory team at our client in Detroit. You will be responsible for overseeing the compliance and quality assurance of clinical trials. This role involves establishing policies, procedures, and training programs to ensure adherence to regulatory standards and the efficient operation of clinical research.
Responsibilities
+ Establish policies regarding enrollment to clinical trials.
+ Develop Standard Operating Procedures for Clinical Trial Activation and Execution.
+ Implement oversight and compliance procedures, including Scientific Review Committee, Feasibility Review Committee, and Data Safety Monitoring Committee.
+ Ensure appropriate training for personnel, including orientation, refresher courses, and competency documentation.
+ Ensure outsourced operational aspects of CCTRO comply with relevant standards and regulations.
+ Establish procedures and resources for internal and external audits and set quality assurance standards.
+ Collaborate with Operations Director to ensure smooth, effective, and compliant research operations.
+ Oversee staff, including Regulatory Coordinator Lead, Clinical Research Finance, and Quality Assurance Coordinator.
Required Skills, Experience and Certifications/Education
+ Bachelor's Degree required.
+ Five years of clinical research experience.
+ People and project management experience.
+ Clinical research certification or ability to obtain it within six months of hire.
Additional Skills & Qualifications
+ Experience in oncology.
+ Proficiency in clinical research management.
Work Environment
The role requires working onsite with some flexibility to work from home one day per week. The Manager will be responsible for managing a team of approximately 20 people.
Job Type & Location
This is a Permanent position based out of Detroit, MI.
Pay and Benefits
The pay range for this position is $95680.00 - $122000.00/yr.
The health and overall well-being of our team members is our priority. We offer a wide range of affordable health insurance options, including three consumer-driven health plans (CDHPs), a PPO plan and an HMO plan. The CDHP plans include a health savings account (HSA) with an employer contribution. And, if you participate in our well-being program, we'll double the employer contribution to your HSA, and you'll have a reduced out-of-pocket cost for your medical coverage. We also offer medical and dental plans unique to the needs of our Canadian employees through ManuLife. Our team members enjoy a number of additional benefits, including: Generous combined time off (CTO) and paid time off (PTO) Dental coverage, including adult orthodontia Family forming benefits, including paid parental leave, adoption, donor assistance and fertility healthcare benefits, and much more Educational benefits, including tuition reimbursement and a dependent scholarship program Retirement plans A large menu of well-being programs and services, including our Employee Assistance Program Comprehensive and extensive work/life resources, including childcare, eldercare, financial, legal and daily living Employer-paid short-term disability and assistance with long-term disability Voluntary, employee-paid benefits, such as critical illness, accident insurance, hospital indemnity, legal services, pet insurance, etc. Discounted group homeowners/renters and car insurance through payroll deduction Free parking A premier purchasing program that allows you to buy electronics, appliances, furniture and other items through payroll deduction Team member discounts for sporting events, local businesses, cell phone services and automobile purchases
Workplace Type
This is a fully onsite position in Detroit,MI.
Application Deadline
This position is anticipated to close on Mar 6, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard 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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.
Apply Now
Apply Now
Job Description
We are seeking a skilled and experienced Clinical Research Manager for the Quality & Regulatory team at our client in Detroit. You will be responsible for overseeing the compliance and quality assurance of clinical trials. This role involves establishing policies, procedures, and training programs to ensure adherence to regulatory standards and the efficient operation of clinical research.
Responsibilities
+ Establish policies regarding enrollment to clinical trials.
+ Develop Standard Operating Procedures for Clinical Trial Activation and Execution.
+ Implement oversight and compliance procedures, including Scientific Review Committee, Feasibility Review Committee, and Data Safety Monitoring Committee.
+ Ensure appropriate training for personnel, including orientation, refresher courses, and competency documentation.
+ Ensure outsourced operational aspects of CCTRO comply with relevant standards and regulations.
+ Establish procedures and resources for internal and external audits and set quality assurance standards.
+ Collaborate with Operations Director to ensure smooth, effective, and compliant research operations.
+ Oversee staff, including Regulatory Coordinator Lead, Clinical Research Finance, and Quality Assurance Coordinator.
Required Skills, Experience and Certifications/Education
+ Bachelor's Degree required.
+ Five years of clinical research experience.
+ People and project management experience.
+ Clinical research certification or ability to obtain it within six months of hire.
Additional Skills & Qualifications
+ Experience in oncology.
+ Proficiency in clinical research management.
Work Environment
The role requires working onsite with some flexibility to work from home one day per week. The Manager will be responsible for managing a team of approximately 20 people.
Job Type & Location
This is a Permanent position based out of Detroit, MI.
Pay and Benefits
The pay range for this position is $95680.00 - $122000.00/yr.
The health and overall well-being of our team members is our priority. We offer a wide range of affordable health insurance options, including three consumer-driven health plans (CDHPs), a PPO plan and an HMO plan. The CDHP plans include a health savings account (HSA) with an employer contribution. And, if you participate in our well-being program, we'll double the employer contribution to your HSA, and you'll have a reduced out-of-pocket cost for your medical coverage. We also offer medical and dental plans unique to the needs of our Canadian employees through ManuLife. Our team members enjoy a number of additional benefits, including: Generous combined time off (CTO) and paid time off (PTO) Dental coverage, including adult orthodontia Family forming benefits, including paid parental leave, adoption, donor assistance and fertility healthcare benefits, and much more Educational benefits, including tuition reimbursement and a dependent scholarship program Retirement plans A large menu of well-being programs and services, including our Employee Assistance Program Comprehensive and extensive work/life resources, including childcare, eldercare, financial, legal and daily living Employer-paid short-term disability and assistance with long-term disability Voluntary, employee-paid benefits, such as critical illness, accident insurance, hospital indemnity, legal services, pet insurance, etc. Discounted group homeowners/renters and car insurance through payroll deduction Free parking A premier purchasing program that allows you to buy electronics, appliances, furniture and other items through payroll deduction Team member discounts for sporting events, local businesses, cell phone services and automobile purchases
Workplace Type
This is a fully onsite position in Detroit,MI.
Application Deadline
This position is anticipated to close on Mar 6, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard 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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.
Apply Now
Apply Now