Job Description

Overview

Director of Monitoring Excellence is a member of the Monitoring Excellence Team reporting to the Global Head of Monitoring Excellence.

Works in close collaboration with the Head of the Regions, GCTO Leadership Team, PSRM, Research Procurement, Functional Service Providers, Monitoring Excellence Colleagues representing the Regions, Business Enablement and IT groups.

Focuses on all aspects related to clinical site monitoring for clinical sites managed by GCTO and/or our Functional Service Partners (FSPs) and full-service CROs

Innovation

• Identifies opportunities for innovative solutions for Site Monitoring and Site Management based on organizational priorities

• Liaises with various internal groups and stakeholders as well as with our external partners and vendors; is involved into developing state-of the-art monitoring paradigms, including, but not restricted to Monitoring Plans, Monitoring Visit Reports, Risk Indicators, escalation triggers and pathways, and signal detection

• Partners with IT to define needs assessments and build vs buy decisions for technology innovations.

• Contributes to the development of forward-looking tools and models to embed Quality by Design (QbD) principles; is an expert and explores closed-loop-feedback, lean six sigma process enhancements, risk-based approaches (RBM) and remote monitoring practices to ensure optimal oversight of clinical trials.

• For internally developed solutions, serves as primary point of contact for coordination of projects with IT partners (e.g. IT PMO, Development team, IT leadership, etc.)

• Oversees project deliverables for major technology projects with significant stakeholder impact

• Develops business cases for prioritized projects to secure and maintain appropriate funding for innovation opportunities

• Establishes appropriate governance structures for projects and coordinate sponsor and steering committee decisions on innovation opportunities

• Coordinates change management to ensure successful realization of innovation projects

Process Improvement

• Leads process improvement projects to enable innovative solutions that improve measures of monitoring performance.

• Leads analytic efforts, initiatives and workstreams to allow immaculate implementation and execution, compliance with established process and metrics. Performs data analysis and shares experience with other groups (QCI, IT, regions) to propel designed use of developed tools, products, metrics.

• Supports implementation of the monitoring tools and approaches, their alignment to business process, sourcing model, initiatives and projects that are connected to monitoring and Monitoring Excellence. Aligns on best practices and approaches to ensure the highest quality standards in site monitoring, standardization of monitoring process, procedures, and supporting guidelines.

• Focuses on technology aspects related to clinical site monitoring for clinical sites managed by GCTO and/or our Functional Service Partners (FSPs). Influences business model and FSP model to ensure it’s congruent to evolving monitoring process, emerging practices, technology, innovation, metrics and standards of premier innovative pharmaceutical company.

• Ensures seamless collaboration with key stakeholders, based on potential impact of projects (e.g., Monitoring Excellence, GCTO Regions, Regional Business System Leads, Business System Owners, GCTO PMO, ESD, MAP, QCI, IT, RBM, Lead SMEs, L&D etc.)

Training

• Management and oversight of global CRA training activities across Monitoring Excellence projects

• Develops training concepts, tools, and materials to support monitoring process, innovative tools and technologies.

• Oversight and Delivery of trainings and leads SMEs, networks, RBSLs, Monitoring Excellence colleagues to the set priorities, deliverables, and implementation milestones.

• Acts as the Monitoring Excellence Primary Point of Contact with Learning and Development and Functional Area Curriculum Lead and Regional Partner Trainers

• Develops Communications to ensure awareness and understanding of Monitoring Excellence projects, initiatives, designed tools and innovative technologies

• Advocates for best practices / change agent activities and initiatives, cooperates with other functions/divisions to create excellence in process management and drug development. Demonstrates and excels in Leadership skills, fosters collaboration, and creates highly productive team environment; identifies and develops talent, engages with mentoring and coaching.

Qualifications, Skills & Experience

• Bachelor's or Master’s degree in Life Sciences or a related medical field.

• Advanced scientific degree (e.g., MS, PharmD, Ph.D.) is an advantage.

• Experience or Certification in Lean/Six Sigma and /or Change Management methodologies is an advantage.

• Experience in working in a global and regional environment with cultural diversity is necessary.

• Experience in technology development and process improvement is required

• Well-developed and effective team facilitation and leadership skills; consistently establishes cooperative team environments. Able to work cross functionally on common goals and objectives.

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Clinical Site Monitoring, Clinical Study Management, Clinical Trial Planning, Communication, English Language, ICH GCP Guidelines, Monitoring Control, Quality Control (QC)

Preferred Skills:

Job Posting End Date:

10/31/2026

*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.