Associate Manager, Clinical Research Compliance and Quality

Job Summary:

The Associate Manager, Clinical Research Compliance and Quality is responsible for overseeing day-to-day quality assurance and compliance activities across clinical research studies, including internal lab studies, investigator-initiated studies, and externally sponsored studies. This role supervises Clinical Research Quality Specialists, manages compliance checks, and ensures that study monitoring documentation and essential files meet global regulatory requirements. The Associate Manager coordinates audit readiness activities, supports inspection preparation, and partners with governance functions to ensure alignment of SOPs, training, and compliance oversight.

Duties & Responsibilities:

• Supervise Specialists and provide oversight of their monitoring and documentation review activities.
• Oversee QA reviews of CRA monitoring documentation for external sponsor studies to confirm adherence to protocols, monitoring plans, and SOPs.
• Perform monitoring visits (SIV, IMV, COV) for internal lab studies and complete associated monitoring reports.
• Conduct compliance checks using the CRC Compliance Check Form to ensure regulatory alignment with FDA, ISO 14155, ICH E6(R2/R3), and EU MDR.
• Track and trend study findings, deviations, audit gaps, and site issues; prepare quarterly compliance dashboards and metrics.
• Lead audit readiness activities, including validation of essential documents, inspection preparation, and CAPA coordination.
• Participate in compliance reviews for CSER support and assist with inspection documentation requests.
• Coordinate with the Governance Specialist to align SOPs, templates, and training requirements with operational practices.
• Support risk-based monitoring by evaluating data trends and developing corrective and preventive action initiatives.
• Collaborate cross-functionally with Clinical Research, Quality, Regulatory Affairs, IT/IS, and Legal to ensure consistent application of compliance standards.
• Leas Internal and External Audit Readiness
• Perform other related duties, responsibilities, or special projects as assigned to support departmental and organizational objectives.

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

• 2 years experience in related field
• Knowledge of Good Clinical Practice (ICH E6[R2/R3]), ISO 14155, and FDA regulations (21 CFR Parts 11, 50, 54, 56, 812).
• Experience with monitoring activities and documentation quality review in a clinical research or medical device environment.
• Strong organizational and project management skills, with ability to oversee multiple studies simultaneously.
• Excellent written and oral communication skills; demonstrated ability to prepare reports and compliance summaries.
• Experience conducting audits, inspection preparation, or compliance checks.
• Ability to manage staff and coordinate work across functional areas

Preferred Qualifications:

• Bachelor's degree in Public Health, Life Sciences, Regulatory Affairs, Nursing, or related field.
• Experience supervising QA or compliance staff in clinical research.
• Familiarity with EU MDR 2017/745 and ISO 13485 quality management systems.
• Professional certification (e.g., ACRP, SOCRA, RAPS, or equivalent) preferred.

Education:

BA/BS or equivalent years of experience required, preferably in life sciences. Advance degree in life sciences preferred.

Compensation

The anticipated salary range for this position is $110,000 - $130,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Travel may be necessary depending on business need. Approximately 20% travel, both domestic and international. Travel requirement is subject to change based on business needs.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.