Technical Project Manager

Responsibilities

• Build and maintain detailed plan for design, build, testing, deployment, run, and closeout of study-level technical deliverables (e.g., eCRFs, data-collection systems, integrations, edit checks/derivations, listings/reports, archival/decommissioning)
• Lead discovery with study stakeholders/SMEs to assess complexity, define technical requirements and inputs/timelines, and confirm the full set of data-management services
• Ensure appropriate use of standards and project-level consistency in database design, data collection, and validation; facilitate standards and change-request intake/processing
• Orchestrate configuration and build of study-level technical deliverables with full traceability to requirements
• Plans across studies; runs risk/change control; aligns stakeholders; provides reliable status reporting and governance updates
• Triage defects and manage change requests with stakeholders and vendors; maintain audit-ready documentation throughout the study lifecycle
• Serve as the primary technical point of contact at the trial level; represent GCDI on cross-functional teams and partners, facilitating decision making
• Ensure all technical components are production-ready before first-patient-first-visit; monitor status/quality pre- and post-release; support end-of-study archival and decomissioning
• Support audits/inspections; ensure validation evidence and documentation meet SOP/GxP expectations
• Identify and oversee process, technology, and standards improvements
• Drive issue triage to closure; coordinates stakeholders and resources
• Prioritize independently; escalates with context, impact, and recommendation to get to timely, quality outcomes
• Qualification and Experience
• Education : Bachelor's degree in computer science, math, or Science
• English: C1
• Experience: 5 years in Software Development or technology implementation
• PM tools: Experience with work tracking programs (e.g., Jira/Confluence), Excel/SQL for simple queries; MS Project or equivalent for timelines
• ETL's - experience with ETL and integrations.
• PM certifications are preferred
• Experience facilitating data migration and integration from different sources preferred

Requirements

• Understanding of clinical research process and the clinical data management (CDM) lifecycle including design, build, validation, and lock / closeout
• Working knowledge of clinical data management systems
• Basic understanding of SDLC and CSV/GxP concepts (e.g., 21 CFR Part 11, Annex 11); follow SOPs/WIs and maintain traceability
• Awareness of data standards and data flow principles
• Ability to lead day-to-day activities including technical team meetings
• Strong communication and negotiation skills, with ability to translate technical topics for non-technical stakeholders and deliver crisp status, decisions, and blockers
• Strong project management skills (planning, execution, change control, RAID management, escalation)
• Strong organization and leadership skills
• Required Skills:
• Adaptability, Clinical Data Management, Clinical Research, Communication, Data Analysis, Data Quality Assurance, Data Reporting, Data Review, Data Validation, Good Clinical Practice (GCP), Medical Terminology, Project Coordination, Teamwork, Vendor Management
• Preferred Skills:
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Additional Information

Job Description The Technical Project Manager is responsible for the end-to-end project management and delivery of technical deliverables for assigned clinical trials within a specific drug/vaccine program. Develops and manages technical project plans which span from design and specification development through production deployment and subsequent change management support. Collaborates with appropriate functional areas to secure and align resources and ensure all aspects of the technical project plan are executed on time and with quality. Engages with cross-functional stakeholders to facilitate delivery of technical data management components based on in-depth knowledge of clinical database standards, technology, and trial specific requirements. Serves as point of contact for in-life maintenance of technical components, manages change requests as necessary, manages customer and stakeholder expectations, facilitates cross-functional decision making, and performs risk management. Represents Global Clinical Data Integration (GCDI) on cross-functional Global Data Management project teams. Participates in the development of, and ensures adherence to, Company's clinical data management procedures. Interacts with staff across multiple Company sites and external vendors.

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Company Intel

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