Job Description
The Senior Business Analyst (BA) – Automation, Analytics & AI (AA & AI) operates at the country level within Global Clinical Trial Operations (GCTO) and Regions & Regional Operations (RRO) to identify, design, and deliver technology-enabled solutions that improve clinical trial operations efficiency, quality, and compliance. The role leads the intake, assessment, and delivery of local automation, analytics, and AI initiatives, creates compelling business cases, builds or oversees development of country tools, and scales fit-for-purpose solutions to other countries or the Region when applicable.
The Senior BA reports to the Clinical Operations Manager Lead and partners closely with country, regional and headquarters roles and teams, such as, Regions Operational Excellence (ROE), regional/country stakeholders, Automation/Analytics/AI partners and, as needed, IT. As needed, the Sr BA may also support initiatives driven by Regional Operations teams, such as GSA, GTO, GSBP and EDM. The role ensures adherence to ICH GCP, company policies, and local regulations, and drives measurable impact through robust KPIs and change enablement.
Key Responsibilities:
Strategy & Intake
- Partner with the CRD, country leadership team, and the AA & AI Lead to surface priority pain points and high-value opportunities for automation, analytics, and AI.
- Lead development of business cases including problem definition, options analysis, solution scope, resource/cost estimates, benefits/KPIs, risks, and compliance considerations.
- Align local opportunities with RRO/GCTO priorities; verify with relevant GCDI/central repositories and teams if there are for similar tools to avoid duplication; summarize reuse opportunities and recommendations for the AA & AI Lead.
Solution Design & Delivery
- Lead and drive the end-to-end delivery of country-level tools and solutions (e.g., dashboards, workflow automation, Robotic Process Automation (RPA), AI-assisted processes) using appropriate platforms and methods.
- For multi-country or regional solutions, co-lead with the AA & AI Lead to ensure harmonization, scalability, and governance alignment.
- Responsible for escalation to centralized assessment when project (?) requirements exceed local capability or scale.
- Translate business requirements into functional/technical specifications and oversee build, testing, validation, and controlled deployment; ensure security, privacy, and quality.
- Conduct life cycle management of the developed solutions, including rollout, maintenance and disposal, as required.
Data, Analytics & Reporting
- Develop or oversee development of analytics and visualization (e.g., operational dashboards, performance metrics) to drive data-informed decision-making.
- Define and track success metrics (e.g., time-to-deploy, cycle-time reduction, accuracy/data quality, adoption/satisfaction, cost avoidance/FTE savings) and embed learning loops for continuous improvement.
Governance, Compliance & Change
- Ensure solutions comply with ICH GCP, Company policies, and local regulations; partner with Compliance/Legal as needed.
- Maintain project tracking and provide periodic updates to CRD, AA & AI Lead, and relevant governance forums; support RRO governance processes.
- Lead change management for local deployments, including training plans, communications, and stakeholder engagement; contribute to capability uplift in data literacy and digital ways of working.
Collaboration & Scaling
- Serve as the primary country liaison with the AA & AI Lead, Automation/Analytics/AI partners, and when required, IT and external vendors for integration and support.
- Share learnings and reusable assets with other countries and regional teams; assess and adapt regional/global tools for local use.
Qualifications, Skills & Experience
Educational Requirements:
- Bachelor’s degree in a life science discipline, business analytics, computing science, engineering, or related field.
Required Experience:
- 5 years of relevant experience in data/analytics, process improvement, or technology-enabled transformation within life sciences/healthcare or a comparable regulated environment which includes:
- Successfully designing and delivering automation/analytics/AI-enabled solutions (e.g., dashboards, RPA/workflow automation, AI/ML pilots) that produced measurable improvements.
- Experience coordinating cross-functional stakeholders, with hands-on project management in a matrix environment.
Preferred Experience:
- Experience working across multiple countries or in regional programs.
- Exposure to integrations with IT/data science teams and vendor coordination.
- Familiarity with clinical trial processes and operational metrics.
- Compliance/regulatory: understanding of ICH GCP and applicable quality and data protection requirements.
Required Knowledge, Skills and Abilities:
- Business process modeling and requirements techniques: e.g., process mapping, user stories, acceptance criteria, functional specifications
- End-to-end product and solution ownership mindset: with accountability for value delivery across the full solution lifecycle (ideation, MVP, rollout, scaling, maintenance, and retirement).
- Data literacy and analytics: ability to translate business questions into metrics; hands-on with BI tools (e.g., Power BI/Tableau) and data querying basics (SQL or equivalent).
- Automation/AI awareness: practical experience with workflow automation/RPA platforms; exposure to AI/ML use cases and constraints in clinical operations.
- Program/project management: planning, prioritization, risk/issue management, and delivery at pace; comfortable with Agile/Lean practices.
- Communication & influence: excellent English communication; ability to influence across functions and present technical topics to non-technical audiences.
- Change enablement: stakeholder engagement, training, and adoption support.
- Problem-solving & critical thinking: structured analysis, hypothesis-driven approach, and pragmatic delivery mindset.
Location
Country-based (office or home-based, per local policy)
Extent of Travel
Up to 10-20% of working time
**Required Skills: **
Adaptability, Business Process Modeling, Clinical Trials, Clinical Trials Operations, Cross-Cultural Awareness, Matrix Management, Process Improvements, Process Mapping, Regulatory Compliance, Robotic Process Automation, Solutions Design, Stakeholder Engagement, Study Management
**Preferred Skills: **
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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
05/12/2026
***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. **