Spclst , Technical Product Management

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/AliCloud).

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 literacyclinical 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/AliCloud environments.

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

Required Skills:

Preferred Skills:

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