Senior Clinical Operations Manager (Regulatory)- REMOTE

Date: May 3, 2019

Location: Rahway, NJ, US

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Requisition ID: CLI008578

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 

This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, Merck policies and procedures and with quality standards internally and externally.   The person has ownership, oversight and impact on local regulatory and financial compliance and for out-tasking as applicable. Under the oversight of the COM manager,  the person is responsible to manage/oversee a team of COMs. 

Responsibilities include, but are not limited to: 
• Has significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up:
COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS:  • Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols, development of local language materials including local language Informed Consents and translations.  • Works in partnership with IRB/IEC and Regulatory Authority in submission and approval related interactions for assigned protocols.

• Responsible for managing country deliverables, timelines and results in assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in the country. Contributes to development of local/Int'l SOPs. 

• Oversees partner workers and local vendors (i.e. Central IRB) and will manage employee COMs (~10 employees).

• Works with minimal oversight from CRD or COM manager in close collaboration internally with GCTO Country Operations (CRM, CTC, CRA, COM and CQM), Medical Affairs, PV, Regulatory Affairs, Business Compliance, MRL/Local finance departments, legal, HQ functional areas and externally with vendors and sites to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. 

• Collaborates closely with Regional Operations and/or Headquarters to align country timelines for assigned protocols. 

• Provides support and oversight to local vendors as applicable. 

• Oversight and coordination of local processes; clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, insurance process management. 

• Enters and updates country information in clinical, regulatory, safety and finance systems.

CORE Competency Expectations: 
• Demonstrates proactive leadership and must be able to in/directly influence investigators, vendors, external partners and country managers to deliver these commitments within specified timelines and budgets, with minimal oversight from the line manager. 

• Skilled knowledge of the Institutional Review Boards (IRBs), legislation and regulatory environment and submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables. 

• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. He/she is an independent decision maker with a clear understanding of the pros and cons of each decision and takes ownership of decisions

• Extensive experience with clinical project management and coordination. 

• Expertise of core clinical, regulatory and financial systems, tools and metrics.

• Extensive knowledge of local regulatory environment and submission and approval processes. • Strong coordination and organizational skills. 

• Demonstrates leadership behaviors  

 Behavioral Competency Expectations: 
• Problem solving and Process Improvement is essential to this position. 

• Ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include:

1) Issues in ICF negotiations

2) Quality and compliance issues

3) Regulatory and legal issues

4) issues related to functional area deliverables that could jeopardize protocol milestones

• Strong communication and leadership skills. • Strong negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal. 

• People management skills (also across countries) will be valued.

• Ability to focus on multiple deliverables and protocols simultaneously is essential.

• Ability to work effectively also in a remote virtual environment with a wide range of people and understanding of cultural differences. 

• Fluency in both English and local language. 


Education Minimum Requirement: 

A Bachelor's Degree required

Preferred:   Master's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related field


Required Experience and Skills**: 
8 years of experience in clinical research  


Preferred Experience and Skills:
Line Manager experience
Study start-up experience in US country operations
ICF (Informed Consent Form) negotiations experience
Project Management experience
Experience managing in a matrix environment


Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 


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Job: Clinical Research Monitor
Other Locations: US
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings: 3
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

Nearest Major Market: New York City
Nearest Secondary Market: Newark

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