Job Description
It is critical that consistent, accurate, high-quality data is generated and maintained from clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead (CQOL) and Head of CQO, the CQOM is responsible for the execution of clinical quality oversight activities within an assigned trial. This includes proactive quality management, risk-based quality oversight, and clinical trial inspection management activities.
The CQOM will provide clinical quality operations support to Trial Teams (TTs) to proactively embed quality into sponsored trials, ensure robust supplier oversight, and address critical quality issues as needed.
The incumbent will assist with the overall strategy for maintaining ongoing inspection readiness, as well as preparing for, managing, and following up on regulatory inspections.
Core Responsibilities:
Trial Team, Research Portfolio and Enterprise Support
Independently support assigned Trial Teams (TT) and drive implementation of Quality by Design.
Act as a Process Subject Matter Expert (SME) within Clinical Quality Operations, providing guidance on quality processes, standards, and regulatory requirements to TTs.
Support identification, investigation, escalation, and resolution of study-level quality issues including Significant Quality Issues (SQIs) and Serious Breaches (SBs).
Support Trial Teams in assessing trial health and conducting quality reviews, as needed.
Lead Inspection Hypercare Teams (IHT) with the aim of ensuring that, at all stages, the Trial Team (TT) maintains ongoing inspection readiness.
Regulatory GCP Inspections & Research and Development Quality Assurance Audits
· Provide oversight for operational management of sponsor inspections (e.g., act as Control Room Lead or Control Room Support).
· Act as Inspection Lead for site inspections.
· Conduct pre-inspection visit (PIV) for impending site inspections.
· Author key inspection communications (e.g., daily summaries, inspection outcomes, and issue escalations).
· Coordinate the inspection response process managing the root cause analysis, Corrective and Preventive Action (CAPA) and associated regulatory commitments to completion, ensuring that key inspection documentation is maintained at all times.
· Support Quality Assurance audits (i.e., Study Level Audits) providing support to TT before, during and after audit, including coordinating root cause analysis for any applicable observations, development of responses, CAPA management and tracking.
Clinical Quality Risk Management
· Collaborate with the Clinical Quality Risk Manager (CQRM) to operationalize quality risk management during trial conduct.
· Provide critical insights from study level audits, inspections, and quality issues and support identification of actionable resolution pathways for quality signals that emerge during trial conduct.
Service Provider Quality Oversight
· Serve as the primary clinical quality Point of Contact (POC) for assigned key service providers (e.g., tier 1 and tier 2 service providers).
· Responsible for the strategic development and management of service provider clinical quality agreements.
Mergers & Acquisitions
· Support quality-related mergers and acquisitions activities, as required, to ensure comprehensive knowledge transfer, risk management, and inspection readiness.
CQO Infrastructure, Process Innovation & Special Projects
· Contribute to the ongoing development of CQO infrastructure and process innovation.
· Support and lead special projects and strategic assignments within CQO as assigned by CQOL.
AI Efficiency & Optimization
· Proactively identify and apply AI-driven approaches to improve operational efficiency and decision-making within CQO.
· Work with data and analytics to monitor performance and drive continuous improvement.
Qualifications, Skills & Experience
Education
· Bachelor's or Master's Degree or equivalent in a health care or scientific area.
Experience
· Minimum of 8 years of relevant experience in the pharmaceutical industry and/or clinical research.
· Robust knowledge of quality management and clinical trial operations.
· Comprehensive knowledge of Quality Management Systems (QMS), ICH GCP guidelines, and worldwide Regulatory Health Authority requirements.
· Advanced experience in independent root cause analysis (RCA), CAPA development and effectiveness management, and service provider quality oversight.
Skills
· Superior oral and written communication skills in an international, matrixed environment.
· Excellent project management and organizational skills.
· Ability to lead cross-functional teams of business and clinical professionals.
· Able to act urgently and decisively on worldwide health authority inspection matters.
· Ability to analyze, interpret, and solve complex quality and compliance issues.
. Ability to think strategically and objectively with digital savvy (awareness of AI and machine learning tools)
eligibleforERP
Required Skills:
CAPA Management, Clinical Quality Management, Communication, Cross-Functional Teamwork, Data Analysis, Good Clinical Practice (GCP), Process Improvements, Project Management, Regulatory Compliance, Regulatory Inspections, Risk Management, Root Cause Identification, Strategic Thinking, Taking Initiative
Preferred Skills:
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US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\EEOC\KnowYourRights\10\20.pdf)
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
The primary location for this posting is:
USA - New Jersey - Rahway
Where required by law, the compensation range for this role is provided below.
The salary range for the primary location of this role is:
$142,400.00 - $224,100.00
This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .
Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.
Additional location(s) Compensation Information:
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Remote
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
10/23/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R422523
