Technical Project Manager

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.

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

Skills

• 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