Live opening · Posted 1 day ago

Director, Digital Health Technology Services, GDMS Data Integration and Automation - Hybrid

Caraway Therapeutics · 2 Locations
Workday
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At a glance

The key details from the original listing.

Posted 1 day ago
CompanyCaraway Therapeutics
Location2 Locations
SourceWorkday
ListedPosted 1 day ago

About the role

Description supplied by the original job listing.

Job Description
The Director, Digital Health Technology (DHT) Services provides multi-team, multi-region leadership and portfolio-level oversight of DHT delivery. This Director approves high-impact designs, balances demand vs. capacity across programs and suppliers, scales automation and best practices, builds long-term capability, represents DHT in governance forums, manages Service Provider performance and escalations, and ensures succession planning within the DHT pillar.
Responsibilities:
DHT System delivery & study execution
Accountable for portfolio and programs SDLC delivery anticipating regulatory/compliance risks and driving product, process, and service improvements while ensuring consistency, scalability, and compliance (GxP, Part 11, Departmental SOPs).
Oversee full lifecycle management across TA portfolio, including pre-production readiness, post-production monitoring, change control, and timely decommissioning/archival with audit-ready documentation.
Hold Service Providers accountable for quality and innovation to achieve strategic milestones and objectives; ensure service levels are met or exceeded.
Build collaborative relationships and take a leadership role to align Service Providers and internal stakeholders on fit-for-purpose solutions tied to study and portfolio milestones, contributing to departmental strategy execution.
Provide oversight for end-to-end delivery of complex data-management activities across multiple studies and systems, anticipating regulatory/compliance issues and solving unique challenges with broad business impact.
Contribute to and shape departmental strategy by initiating and leading high-impact projects and initiatives.
Data integration, quality & system operations:
Oversight of end-to-end data integrity and compliance across all studies and systems, proactively identifying internal/external risks and recommending improvements.
Monitor data integrations and quality, ensuring robust interoperability (APIs, files, schedules), resiliency, and error handling; anticipate systemic issues; support defect triage and drive timely resolution.
Provide technical leadership, guidance, and reviews; advise on design trade-offs and complex data mapping/reporting/archiving.
Governance, compliance & continuous improvement:
Contribute to departmental strategy by establishing and scaling TA-level standards, templates, and design patterns for DHT setup, flows, and reporting that improve products, processes, and services.
Represent DHT in governance and leadership and industry forums, anticipate emerging business and regulatory issues, and recommend strategic actions.
Drive process optimization and technology enablement; identify and implement improvements (templates, test automation, dashboards); scale best practices and tools.
Partner with DI&A and data standards teams on roadmaps and alignment to enterprise data strategy.
Lead adoption and change across Service Providers and internal stakeholders to standardize DHT systems, acting as facilitator and mentor to empower others.
Anticipate and prepare for regulatory inspections and audits, leading readiness with expert guidance.
Define OKRs/KPIs; report organizational performance, risks, and investment needs; recommend data-driven actions to leadership.
Ensure maintenance of SOPs, reference documents, and execution resources relevant to DHT setup and operations.
Lead capability building: define curricula, mentorship models, and competency frameworks; champion knowledge sharing and communities of practice; provide input into succession planning.
Provide leadership for training and education for stakeholders, develop training materials, and support onboarding and recognition programs.
People Management:
Align teams around a clear direction; set clear objectives aligned to organizational goals; assign work and set priorities accounting for work-life balance sustainability.
Conduct regular check-ins and annual reviews; coach for performance; provide recognition.
Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring.
Lead recruiting and hiring and oversee performance management activities, including management of sensitive employee-relations matters in partnership with HR.
Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs.
Manage an operating budget and optimize spend against priorities.
Inspires and ensures that team leaders are effectively supporting and empowering their team members.
Technical skills:
Advanced expertise with electronic Clinical Outcome Assessment (eCOA) or Digital Health Technology (DHT) platforms used in clinical trials
Expert-level knowledge of the clinical development process, DHT, electronic data capture, preferably through submission; thorough knowledge of clinical data management.
Advanced understanding of UAT processes, system validation, and regulatory compliance requirements for clinical data systems
Demonstrated ability to set TA-wide requirements for DHT configuration, integration, validation, and observability.
Soft skills:
Distill complex issues into decision-ready narratives; frame options, risks, and recommendations to influence senior decisions.
Strong influence skills and able to drive adoption of standardized methods/ways of working; mobilize cross-functional champions and measure uptake.
Align senior stakeholders on objectives, interfaces, and responsibilities; enforce clean handoffs and resolve conflicts.
Coordinate decisions across regions/time zones; use asynchronous mechanisms to maintain momentum.
Apply strong project management skills to drive on-time, high-quality delivery; lead technical team meetings, coordinate resources, and communicate status, risks, and mitigations to senior leadership.
Ability to evaluate platforms, build vs. buy, PoCs, performance/cost trade-offs at scale.
Ability to engage Service Providers, leadership, and industry forums; represent the team professionally and credibly under pressure; maintain resilience and composure
Ability to define and execute organizational strategy for operations across regions
Demonstrated success managing large, diverse, and geographically distributed teams
Strong understanding of operational, financial, and compliance dimensions of global data delivery
Capable of leading transformation initiatives and fostering innovation across complex organizations
Excellent communicator with the ability to translate technical and operational priorities into clear, actionable direction
Lead through influence across functions/geographies; mentor global cohorts; provide structured feedback.
Enterprise Leadership Skills:
Strategic Planning | Plan strategically by gathering information and identifying key issues, dependencies, and relationships critical to achieving long-range goals; commit to a course of action after developing and evaluating alternatives based on facts, available resources, constraints, and organizational values.
Networking & Partnerships | Cultivate networks and partnerships by initiating and maintaining strategic relationships with stakeholders and potential partners inside and outside the organization who provide the information, ideas, expertise, and influence needed to deepen understanding of business issues and achieve business goals.
Change Catalyst | Lead change by driving the organizational and cultural shifts needed to achieve strategic priorities; catalyze new approaches to improve results by evolving culture, systems, and services; help others overcome resistance and adopt change.
Qualifications & experience:
Bachelor's Degree, preferably in life sciences, computer science, engineering or related discipline with a minimum of 10 years’ experience in DHT domain or equivalent relevant industry experience including a minimum of 3+ years people management experience.
Demonstrated deep Subject Matter Expertise.

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