Sr Spclst, Study Integration Project Manager

Job Description

The Senior Specialist, Study Integration Project Manager, GDMS Data Integration and Automation is responsible for leading the planning, execution, and oversight of study-level technical deliverables. This role ensures seamless configuration, integration and quality assurance of systems supporting global clinical trials

Responsibilities

Study technical planning & delivery

• 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/subject matter experts 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.

Cross-functional coordination, risk & governance

• 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 service providers; maintain audit-ready documentation throughout the study lifecycle.

• Serve as the primary technical point of contact at the trial level; represent DI&A on cross-functional teams and partners, facilitating decision making

Standards, quality & continuous improvement

• 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 decommissioning.

• Support audits/inspections; ensure validation evidence and documentation meet SOP/GxP expectations.

• Identify and oversee process, technology, and standards improvements

Technical 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.

• Experience with work tracking programs (e.g., Jira/Confluence), Excel/SQL for simple queries; MS Project or equivalent for timelines.

• Awareness of data standards and data flow principles

• Experience with business intelligence tools for reporting and workflows

Non-technical skills

• Ability to lead day-to-day activities including technical team meetings

• Drives issue triage to closure; coordinates stakeholders and resources

• Prioritizes independently; escalates with context, impact, and recommendation to get to timely, quality outcomes

• 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)

Enterprise Leadership Skills

• Decision Making | Identifies and understands problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; solves complex problems and applies knowledge of business challenges; able to weigh multiple options and implications

• Motivation & Inspiration | Communicates effectively, promotes teamwork and open discussion, effectively communicates and engages / motivates teammates; inspires others toward higher levels of performance aligned with organization's Purpose and Strategic Framework

• Coaching & Development | Builds self-insight, demonstrates awareness of own strengths and development needs as well as impact of own behavior on others; modifies behavior based on self-awareness to improve impact, serves as a resource for collogues, coaches, and guides others.

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

Required Skills:

Preferred Skills:

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