Job Description

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

To ensure we receive high quality data from the investigational sites around the globe, our Clinical Research systems have to be compliant with regulatory requirements and follow our SDLC policy. Clinical Systems Quality Manager will be responsible to ensure our clinical systems are developed, validated and implemented while following high quality standards.

Under the guidance of Head BEO and in collaboration with IT PM and Business System Owners the CSQM will oversee the quality and regulatory requirements of IT systems across Global Clinical Development (GCD), Global Regulatory Affairs & Clinical Safety (GRACS). This role is one of three core responsibilities mandated by corporate policy 13.5. This role has approval responsibility for any changes to the GxP systems within above organizations.

CSQM SDLC: CORE Accountabilities and Responsibilities

• Responsible for performing quality activities as it relates to GxP automated and computer systems compliance within GCD & GRACS. Works with IT, Business System Owners and the User Community to provide quality services associated with the validation and compliance of automated computer systems (e.g. Change Control, Doc. Management, etc.).

• Assist in proper validation strategy, review of project/department deliverables to ensure adherence to our policies and procedures. Act as the quality gate at various project checkpoints. Manage the completion of quality review activities to ensure they are completed in a consistent and timely manner across multiple automated and computer systems.

• Manage automated and computer system related quality activities (e.g. change control, periodic computer systems review, etc.) providing consistent quality guidance across GCD and GRACS business areas. .

• Provide communications/presentations on quality topics surrounding computer validation to Sr. Management, provide validation guidance for GCP computer systems, participate in corporate, departmental audits and regulatory inspections, assess and determine corrective action for automated or computer system compliance related issues.

CQSM SDLC: OTHER Accountabilities and Responsibilities

• Communication and Oversight: Collaborate with IT system development teams, Business System Owners, Quality & Continuous Improvement (QCI) staff other GCD & GRACS stakeholders to implement quality management tools and procedures to be used developing IT systems according to SDLC Policy 13.5.

• Training: Actively collaborate with our Research and Development Division Learning & Development and SDLC Policy Owner to support the development and implementation of SDLC related training

• Process Improvement: Collaborate with IT, Business System Owners and other stakeholders to improve the processes and increase the efficiency in using IT systems to increase the productivity in Clinical Research

• Trend Analysis and CAPA: Liaise with Global Clinical Compliance GCC and GCTO CAPA Management to monitor trends from system audit findings and assist in response to audit and inspection findings of GCD and GRACS IT systems

Education:

• Bachelor's degree in Computer Science, Computer Information Science or related area.

Experience:

• Five years of end-to-end computer system validation experience required.

• Experience in automated or computerized system compliance, project management principles, systems analysis and systems maintenance/support required.

• Position requires experience with an automated or computerized system Software Development Life Cycle (SDLC) methodology in a regulatory environment.

• Requires experience in reviewing validation deliverables.

• Knowledge and understanding of Clinical Trial processes as well as quality management and control tools is preferred.

• Direct experience in quality management, Auditing and supporting Inspections.

• Experience in Root Cause Analysis, identification and documentation of appropriate corrective and preventive actions.

Skills:

• Requires management and leadership skills, analytical ability, good judgment, ability to multi-task

• Customer service orientation and the ability to work effectively with clients, third party vendors, quality and IT management/staffs

• experience in training user communities preferred.

• Strong verbal & written communication skills

• Excellent teamwork collaboration and leadership skills, including conflict resolution expertise and discretion.

• Ability to proficiently interact with all levels of management and exert influence to achieve results.

clinicaltrialjobs

EligibleforERP

Required Skills:

Accountability, Accountability, Adaptability, Business-IT Alignment, Clinical Development, Clinical Quality Management, Clinical Research, Clinical Trial Compliance, Clinical Trial Development, Clinical Trials, Clinical Trials Monitoring, Clinical Trials Operations, Data Analysis, Dedication to Patient Care, Ethical Standards, Good Clinical Practice (GCP), ICH GCP Guidelines, IT Project Lifecycle, IT Systems Development, Leadership, Leadership Mentoring, Management Process, Pharmaceutical Regulatory Affairs, Quality Assurance Processes, Quality Management {+ 4 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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 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:

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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

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$114,700.00 - $180,500.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

No

Job Posting End Date:

01/28/2026

*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.