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General Description:

The Associate Director, Digital Clinical Operations - Project Lead, is responsible for coordinating and managing digital initiatives within Global Clinical Operations (GCO) to enhance the effectiveness, efficiency, and compliance of operational systems and processes. This role ensures that digital projects and system enhancements are strategically planned, well-governed, clearly communicated, and executed with discipline and transparency.

The candidate will serve as a central point of coordination between business stakeholders, IT, QA, and vendor partners, supporting the delivery of prioritized projects under the Digital Clinical Operations (DCO) portfolio. The role emphasizes operational structure, project execution excellence, and continuous process refinement to ensure digital capabilities meet business needs and regulatory standards.

The Associate Director is expected to:

+ Coordinate and oversee the delivery of digital projects and system enhancements from initiation through deployment.

+ Serve as the primary liaison between business stakeholders, IT, QA, and vendors to ensure clear communication, alignment, and timely delivery.

+ Manage project intake, prioritization, and tracking processes, maintaining transparency and traceability.

+ Ensure all initiatives adhere to established SDLC or Agile frameworks, documentation, and validation standards.

+ Monitor progress, risks, and interdependencies, escalating issues proactively to maintain delivery momentum.

+ Develop project communication materials, including release summaries, stakeholder updates, and governance dashboards.

+ Support operational efficiency by optimizing project management and governance processes.

+ Maintain compliance with GxP, validation, and change control standards through structured documentation and oversight.

+ Contribute to the continuous improvement of DCO project governance, reporting, and delivery frameworks.

Essential Functions of the job:

Project Planning & Execution

+ Lead or support planning and coordination of multiple concurrent digital initiatives across the DCO portfolio.

+ Define project scope, deliverables, and timelines in collaboration with business and IT stakeholders.

+ Manage validation deliverables and ensure adherence to quality and compliance standards.

+ Track milestones, risks, and dependencies, maintaining visibility and accountability.

Governance & Communication

+ Administer structured project intake, review, and approval processes.

+ Facilitate governance discussions, document decisions, and communicate status updates.

+ Ensure consistent stakeholder engagement and transparent communication across functions.

Compliance & Quality Oversight

+ Ensure all project activities comply with GxP, 21 CFR Part 11, and internal quality management procedures.

+ Maintain audit-ready documentation for all project activities.

+ Promote adherence to change control, testing, and release documentation requirements.

Cross-Functional Collaboration

+ Partner with business, IT, and QA functions to ensure cohesive project execution.

+ Collaborate with analytics and process teams to enable data integrity and operational readiness.

+ Support knowledge sharing, best practices, and continuous improvement across DCO initiatives.

Education/Experience Required:

+ Bachelor’s degree in Life Sciences, Information Systems, Computer Science, or a related field.

+ 8+ years of project management experience in Clinical Operations or Clinical Systems Management within a regulated (GxP) environment.

+ Familiarity with SDLC and Agile methodologies for validated systems.

+ Knowledge of Oracle Siebel CTMS or similar systems along with PMP or Agile certification preferred.

**Computer skills:** Proficient in Microsoft Office (Excel, PowerPoint, Project), Smartsheet, and collaboration tools.

**Other Qualifications:** Strong understanding of clinical trial processes, systems (CTMS, EDC, eTMF), and regulatory standards. Familiarity with Lean Six Sigma or continuous improvement methodologies preferred.

**Travel:** Up to 20% (domestic and international)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.