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 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/AliCloud 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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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.