Key Responsibilities and Required Skills for Clinical Quality Manager

🎯 Role Definition

The Clinical Quality Manager develops, implements and maintains clinical quality systems and processes to ensure compliance with global regulatory requirements (GCP, GMP where applicable) and internal policies. This hands-on manager leads internal and vendor audits, manages CAPA and risk mitigation activities, supports regulatory inspections and clinical safety investigations, and partners with clinical operations, regulatory, pharmacovigilance, data management and manufacturing teams to protect patient safety and data integrity throughout the clinical development lifecycle.

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Research Associate (CRA) transitioning into quality oversight
Quality Assurance Specialist or Quality Engineer with clinical exposure
Regulatory Affairs Specialist with clinical trial experience

Advancement To:

Senior Clinical Quality Manager
Director of Clinical Quality / Head of Clinical Compliance
VP Quality, Clinical Operations Leadership

Lateral Moves:

Clinical Operations Manager
Regulatory Affairs Manager
Pharmacovigilance / Drug Safety Lead

Core Responsibilities

Primary Functions

Develop, implement and maintain the clinical Quality Management System (QMS), including SOPs, work instructions, templates and quality metrics, to ensure consistent compliance with GCP, applicable GMP and global regulatory expectations.
Own and execute the clinical audit program: plan, schedule, conduct and report internal and external audits of clinical sites, vendor partners (CROs, labs, IVRS/IRT vendors), investigators and internal processes; drive timely CAPA and verification activities to closure.
Lead and coordinate vendor and CRO oversight activities including vendor qualification, periodic performance review, on-site and remote audits, audit follow-up and oversight of corrective and preventive actions.
Manage CAPA program lifecycle: investigate deviations and non-conformances using formal root cause analysis (e.g., 5 Whys, fishbone), design corrective and preventive actions, document impact assessments and verify effectiveness.
Serve as primary clinical quality liaison for regulatory inspections and sponsor audits (FDA, EMA, MHRA and other Health Authorities): prepare inspection packages, lead mock inspections, coordinate responses and implement inspection follow-up actions.
Author, review and approve clinical quality documentation including SOPs, quality plans, audit reports, inspection responses, CAPA records, deviation reports and quality metrics dashboards.
Drive continuous improvement initiatives using quality tools (risk assessments, process mapping, Six Sigma/Lean where applicable) to reduce study risk, improve efficiency and strengthen compliance culture.
Oversee clinical safety and compliance investigations including serious adverse event (SAE) review processes, coordinated communication with pharmacovigilance, and implementation of systemic corrective actions when required.
Monitor and report quality KPIs and trends (audit findings, CAPA aging, deviation rates, vendor performance) to senior leadership and use data to prioritize quality activities and resource allocation.
Ensure eTMF integrity and oversight: implement eTMF quality checks, manage quality review processes, remediate missing or inconsistent documents and support inspection-ready eTMF outputs.
Lead change control and deviation management for clinical processes: assess regulatory impact, coordinate cross-functional stakeholders and manage approvals and implementation.
Provide GCP and QMS training for study teams, vendors and investigators; develop targeted training plans to remediate gaps identified through audits and inspections.
Collaborate with clinical operations to design monitoring strategies (on-site and remote) and support quality-focused monitoring activities, including statistical monitoring and source data verification plans.
Support data integrity activities by partnering with data management and biostatistics to ensure clinical data accuracy, query resolution processes and appropriate controls for electronic systems (ALCOA+ principles).
Manage quality aspects of vendor and investigator contracts and quality agreements, ensuring defined responsibilities, audit rights and compliance expectations are documented and enforced.
Participate in protocol and trial design reviews to identify quality and compliance risks early and recommend mitigations to decrease the likelihood of protocol deviations and regulatory issues.
Conduct supplier and third-party vendor risk assessments and implement risk-based monitoring and oversight proportional to the vendor’s impact on data integrity and patient safety.
Prepare, review and approve clinical trial quality sections of regulatory submissions, inspection packages, and responses to regulatory queries related to quality systems.
Chair or participate in cross-functional quality governance meetings, steering committees and management reviews to ensure visibility of quality risks and alignment of remediation activities.
Lead investigation and remediation of systemic or recurring compliance issues across studies or sites; implement preventive controls and report outcomes to leadership and stakeholders.
Coordinate with manufacturing and supply chain quality teams when clinical product or device related quality events occur, ensuring timely communication and CAPA alignment across functions.
Mentor and develop junior quality staff; build a high-performing quality team by defining roles, setting objectives and conducting performance assessments.
Maintain inspection readiness across clinical programs by performing periodic mock inspections, readiness assessments and implementing targeted remediation plans.
Ensure electronic systems used in clinical trials (CTMS, eTMF, EDC, eConsent) are assessed for compliance, including supplier audits, system validation status, and evidence of appropriate controls.

Secondary Functions

Support ad-hoc quality data requests, metrics reporting and exploratory trend analysis for leadership and regulatory responses.
Contribute to the organization’s quality strategy and roadmap, aligning clinical quality initiatives with corporate risk appetite and business objectives.
Collaborate with business units to translate clinical quality needs into operational requirements for CTMS, eTMF and QMS tool configuration.
Participate in agile project planning and cross-functional initiatives to implement continuous improvement projects and digital quality solutions.
Provide subject matter expertise for business development and due diligence activities related to clinical quality and regulatory compliance.

Required Skills & Competencies

Hard Skills (Technical)

Deep knowledge of GCP (ICH E6), and applicable GMP requirements where clinical supply or device interactions occur; strong understanding of FDA, EMA, MHRA inspection expectations and international regulatory frameworks.
Proven experience designing and executing audit programs (site, sponsor, vendor/CRO audits) and producing high-quality audit reports and CAPA plans.
Root cause analysis and CAPA management techniques (5 Whys, fishbone, FMEA), and demonstrated success verifying effectiveness of corrective actions.
Quality Management Systems (QMS) design and maintenance, including SOP authoring, document control, deviation handling and management review processes.
Hands-on experience with eTMF, CTMS, EDC and other clinical systems; familiarity with eTMF quality checks, system validation and audit trails.
Risk-based monitoring and risk assessment methodologies for clinical trials (RBM, RBQM) and clinical operations.
Proficiency with quality metrics, dashboards and basic statistical trend analysis tools (Excel, Power BI/Tableau preferred) to support data-driven quality decisions.
Experience supporting regulatory inspections, creating inspection responses and managing timelines and stakeholders during regulatory engagements.
Knowledge of vendor management and quality agreements — drafting, negotiating and enforcing quality clauses with CROs and third-party providers.
Experience with electronic records and signatures validation (21 CFR Part 11), CSV principles and documentation of computerized system compliance.
Familiarity with pharmacovigilance interfaces and SAE handling processes to ensure coordinated quality and safety oversight.

Soft Skills

Strong leadership with ability to influence cross-functional teams and senior stakeholders without direct authority.
Excellent written and verbal communication skills, able to produce inspection-ready documents and present complex quality issues clearly.
Analytical and problem-solving mindset with attention to detail and ability to prioritize competing quality risks under tight timelines.
Coaching and mentoring skills to develop junior quality professionals and foster a continuous improvement culture.
Stakeholder management and negotiation skills for effective vendor oversight and contract quality discussions.
Adaptability to evolving regulatory landscapes and ability to drive change across matrixed organizations.
High ethical standards and commitment to patient safety, scientific integrity and compliance.

Education & Experience

Educational Background

Minimum Education:

Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Biomedical Engineering, Public Health or related field.

Preferred Education:

Master’s degree (MS, MPH, MBA) in a relevant discipline, or professional degrees such as PharmD, RN, or equivalent clinical/technical qualification.
Formal quality management training or certification (e.g., CQE, CQA, Six Sigma, ISO 9001 lead auditor) is highly desirable.

Relevant Fields of Study:

Clinical Research / Clinical Science
Nursing, Pharmacy or Biomedical Sciences
Regulatory Affairs, Quality Assurance, Public Health

Experience Requirements

Typical Experience Range: 5–10+ years in clinical quality assurance or related roles, with progressive responsibility.

Preferred:

At least 3–5 years managing clinical quality programs and vendor/CRO oversight.
Demonstrated experience supporting regulatory inspections and leading audit/CAPA programs in a biotech, pharmaceutical or medical device environment.
Hands-on experience with eTMF/CTMS systems and demonstrated ability to implement or improve clinical QMS components.