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Senior Manager, Clinical Quality Management

Remote:

Full Remote

Contract:

Full time

Experience:

Expert & Leadership (>10 years)

Work from:

Illinois (USA), United States

Offer summary

Qualifications:

BS in life sciences, 10 years relevant experience, Comprehensive understanding of GCP, CFR and ICH guidelines.

Key responsabilities:

Ensure SOP compliance and updates
Implement QMS and lead QA team
Generate and analyze quality metrics
Manage audit program and inspections
Support quality improvement interventions

ICONMA Human Resources, Staffing & Recruiting Large https://www.iconma.com/

1001 - 5000 Employees

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Job description

Your missions

Senior Manager, Clinical Quality Management

Location: Remote
Duration: 6 months

Description:
Education & Experience Type of Experience
BS in life sciences discipline
10 years of relevant experience

The Sr. Manager, Clinical Quality Management for the RWE Clinical Trial business will be responsible for the management and operational oversight of the quality activities for the broader business and clinical trial site level to ensure client conducts is trials to the highest quality and regulatory obligations and enhances performance through continuous improvements.
This will also include the need to proactively assess and identify risks, tackle unplanned deviations, corrective/preventative actions, and proactive monitor and trending of quality issues to ensure business is performing to Good Clinical Practice (GCP) standards.

Comprehensive, excellent understanding of GCP, CFR and ICH guidelines
Significant experience with managing clinical quality activities and in-depth knowledge of clinical operations.
Significant experience in with clinical trial site/process audits and regulatory inspections
Experience in line management of employees.
Experience translating Pharma/Sponsor needs for innovation and creative approaches to quality management.
Excellent leadership and interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team.
Excellent verbal and written communication and presentation skills.
Demonstrated adaptability, flexibility, independence and resourcefulness to thrive in a start-up environment.

Ensure Standard Operating Procedures (SOPs) and Internal Operating Procedures are reviewed periodically and advise on required updates to ensure compliance with ethical, regulatory and other relevant frameworks, making recommendations for improvement where appropriate.
Identify appropriate staff SOP training requirements and maintain oversight of training to ensure all client clinical trials staff are trained on SOPs Ensure staff SOP training requirements are achieved for QA and
Implement and maintain a Quality Management System (QMS) in line with the Corporate QMS and take the lead in presenting it to internal stakeholders, pharmaceutical companies and other funding partners.
Build, manage, lead and motivate a QA team, ensuring that people with the right range of skills and experience are recruited and retained, and that their skills and professional capabilities are maximized.
Ensure quality and operational compliance; act as a subject matter expert for quality investigations, documentation systems, training programs, internal/external audits, and vendor assurance programs.
Develop and implement a risk-based and flexible approach to QA in compliance with applicable regulatory requirements.
Generate and analyze weekly, monthly and quarterly metrics to track KPIs
Work with Operations team to implement, review and maintain tracking of incidents within the clinical trials, advising on CAPAs to be implemented and ensure completion in a timely manner.
Lead the Audit Program management process, including assessment of internal and external (outsourced) operations, and active audit and regulatory inspections.
Partner with functional areas in study design, data collection, and analysis, and reporting activities that support quality improvement interventions, transparency, compliance with regulatory standards, and provide performance monitoring.

As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Required profile

Experience

Level of experience: Expert & Leadership (>10 years)

Industry :

Human Resources, Staffing & Recruiting

Spoken language(s):

Check out the description to know which languages are mandatory.

Hard Skills

Account Reconciliation

Soft Skills

strong-work-ethic
verbal-communication-skills

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