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
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