Job Description:

R393871

Description

This role is collaborated with team and responsible for owning and continuously improving Innovation Collaboration Center core clinical development systems, ensuring they effectively support end-to-end study delivery. Working closely with cross-functional stakeholders and external vendors, the role sets priorities, drives enhancements, and ensures stable operations, compliant processes (GxP/CSV), and seamless data/system integration in a cloud environment (AWS/Ali Cloud).

Key Responsibilities

• Collaborate with Product team to own the end-to-end lifecycle for core clinical development systems (~10 systems including IRT/RTSM, EDC, Medical Review, CTMS, eTMF, PV database, statistics & analysis platform, Data Room, project management (Microsoft Power Platform), eCOA/ePRO, etc.), from intake and roadmap through release, operations, and retirement.

• Defines product vision, strategy, and roadmap aligned to clinical development objectives, compliance requirements, and user experience; establishes OKRs/KPIs for value realization.

• Leads demand intake and prioritization with business stakeholders; makes product decisions and trade-offs to maximize patient safety, data integrity, delivery predictability, and total cost of ownership.

• Understands end-to-end clinical R&D processes (protocol to database lock to safety reporting) and statistical/analytical needs for pharma R&D (e.g., clinical data review and analysis readiness); anticipates evolving needs (e.g., decentralized trials, real-time data review, automation, and analytics enablement).

• Defines and monitors product metrics (adoption, incident/defect trends, system performance/availability, cycle time, release success rate, validation/compliance status, cost/TCO).

• Drive continuous discovery with Clinical Ops/DM/PV/QA to uncover pain points and translate them into requirements, user stories, and solution options (configuration, integration, automation, or process change).

• Maintains a prioritized backlog and release plan; owns cross-system dependency management and end-to-end integration delivery (interfaces, data flow, reconciliation) to ensure coherent data movement from EDC through PV and analytics consumption.

• Drives user adoption and change management: training enablement, communications, SOP/process updates, and continuous feedback loops with study teams.

• Leads release, validation/compliance, and support planning (including GxP considerations, vendor coordination, cutover, and hypercare) to ensure stable operations and inspection readiness.

• Acts as the primary interface between business stakeholders, IT delivery/operations, and external vendors; facilitates clear communication, issue resolution, and timely decisions.

• Manages product financials and vendor contracts where applicable; continuously optimizes operating model and total cost of ownership (licenses, services, infrastructure, and support effort).

• Ensures fit-for-purpose governance and documentation (e.g., requirements, configurations, integrations, risk/issue logs, and validation evidence) in partnership with QA/Compliance and IT.

Skills

• Required / Core: Fluent English as working language (written and spoken); able to communicate effectively with global teams and vendors.

• Required / Core: Strong presentation and stakeholder communication skills; able to synthesize complex topics and drive decisions with cross-functional audiences.

• Required / Core: Pharma R&D statistics and analysis literacy—clinical trial data concepts, data review/analysis readiness, and ability to translate analysis needs into system/product requirements (e.g., awareness of CDISC SDTM/ADaM is a plus).(Either this or the clinical development domain knowledge below is acceptable; both is preferred.)

• Required / Core: Clinical development domain knowledge across the study lifecycle (protocol to database lock to safety reporting) and understanding of how clinical systems support delivery (e.g., IRT/RTSM, EDC, eTMF, CTMS, eCOA/ePRO, medical review, PV, analytics platforms).(Either this or the statistics/analysis literacy above is acceptable; both is preferred.)

• Optional / Plus: Basic awareness of compliance in clinical development, including GCP principles and computerized system validation (CSV) / GxP requirements.

• Optional / Plus: Technical product management (product vision/roadmap, backlog, OKRs/KPIs, value metrics).

• Optional / Plus: Requirements, process & change management experience in a regulated environment.

• Optional / Plus: Vendor & delivery management (SaaS providers, SLAs, issue management, contract/financial management).

• Optional / Plus: System & data integration fundamentals (APIs/interfaces, ETL, reconciliation, data standards, cross-system workflows, downstream analytics).

• Optional / Plus: Cloud fundamentals (SaaS/PaaS/IaaS, IAM, security, monitoring) in AWS/Ali Cloud environments.

• Optional / Plus: Service & operations management (incident/problem/change, SLAs, continuous improvement).

Required Skills:

Professional Presentation, Project Management, R&D Engineering, Stakeholder Communications, Statistical Analysis

Preferred Skills:

Change Management, Clinical Compliance, Data Systems, Product Management

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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:

No Travel Required:

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

08/31/2026

**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.