Sr Spclst, Study Integration Project Manager

Job description

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: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 09/26/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.