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:

Adaptability, Adaptability, Clinical Data Management, Clinical Research, Communication, Competency Management, Compliance Activities, Coordinating Resources, Cross-Functional Project Management, Data Analysis, Data Auditing, Data Compliance, Data Management, Data Quality Assurance, Data Reporting, Data Review, Data Standards, Data Validation, Enterprise Leadership, Good Clinical Practice (GCP), Medical Terminology, Organizational Leadership, Prioritization, Process Implementations, Process Improvements {+ 8 more}

Preferred Skills:

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

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Hazardous Material(s):

Job Posting End Date:

09/26/2026

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