MANAGER, SOLUTION DELIVERY AND INTEGRATION Resume Lake Forest, IL - Hire IT People

SUMMARY:

Business and technology leader with proven success developing enterprise solutions for pharmaceutical and medical device manufacturers. s in pre - clinical, clinical, and on-market product and solution delivery phases. Program and project roles include development, delivery, and support of GxP systems/services for business acquisition and divestitures, clinical data management, and new workflow delivery.

SKILL:

Enterprise Software Solutions Development, Configuration, Delivery, and Support | SDLC Management
Quality Assurance | Clinical and Safety Data Management | CRO CRM | Clinical Trial Study Management
Complaint Management | Data Lake Development | Pharmacovigilance | Drug Development | eCTD and Regulatory Submissions | GCP | GMP | Process and Test Method Validation | GLP Systems Management | Consulting | Business Analysis and Reporting | Master and Professional Service Agreements | System Separation and Migration | IaaS-PaaS-SaaS Solution Management |Software Procurement and Licensing | Vendor Selection and Partnerships

TECHNICAL SKILLS AND COMPUTER APPLICATIONS:

Analytics-BI Reporting (Business Objects; J-Review; MATLAB; NCSS ROC; Power BI; SAS; SpotFire, Tableau)
CAD (ANSYS; AutoCAD; SolidWorks)
Clinical Data Management (Clintrial, EDC DataTrak, Inform, Oracle Clinical, PKS PD/PD Deployment)
Cloud Solution DevOps and Delivery (AWS Solution Architect Associate; MS Azure Administrator)
Complaint Management / Pharmacovigilance (Clintrace, ArisG, Argus, TrackWise);
CRO CRM (Trial Study Management); Coding Thesaurus Management (MedDRA, ICD-9 CM; WHODRUG via Oracle TMS, I-Review/J-Review); Site Selection/ Activation; IB and IRB (Protocol, DMP, Payments, Supplies)
Code Change Management (GitHub/GitLab; IBM ClearCase; ClearQuest; JIRA-Confluence; VSS)
Defect Tracking |Quality Management| Process and Test Method Validation (HP Quality Center/ALM)
Design Control Management (IBM DOORS; SolidWorks; DMS)
Document Management (Documentum; eRoom; SharePoint 2013 Site Administration; SAP-DMS)
Enterprise Change Management and Solution Delivery (GoToAssist; REMEDY,ServiceNow, ServiceCenter)
GLP System Management: LIMS (ThermoFisher), CDS (Waters EMPOWER), SDMS (Waters NuGenesis)
MS PowerShell scripting for Azure (AZ-102;103)
Product Life Cycle Management (3DS ENOVIA PLM; BIOVIA Electronic Lab Notebook/Pipeline Pilot)

EXPERIENCE:

Confidential, Lake Forest, IL

MANAGER, SOLUTION DELIVERY AND INTEGRATION

Responsibilities:

Manage system divestiture activities with Confidential business partners per Transitional Services Agreement (data and system migration; dataset extractions and archival).
IT Solution Delivery Manager for over 23 QMS systems, including SaaS clinical studies EDC.
Technical Lead for TrackWise QMS production Data Warehouse/BI Reporting system.
Led development and release of AWS Cloud DevOps environment for IBM DOORS RMS.

Confidential, Lake Forest, IL

PRINCIPAL ANALYST

Responsibilities:

Technical Lead for global DHF system upgrade (590+ user base) ; LIMS system (450+ user base) and RnD-QMS Warehouse-Archive system upgrades: led as direct vendor contact and author of RFP, Master Service Agreement, project-specific statements of work.
Led development of RnD Data Lakes for use in product quality and storage facility monitoring reports using database Data Warehouse, simple table storage, and Tableau/Power BI.

Confidential, Jersey City, NJ

SOLUTIONS MANAGER

Responsibilities:

Managed early phase design of Global Complaints and Reporting system upgrade enabled acceleration of project schedules re-purposed for development testing.

Confidential, Bannockburn, IL

PROJECT MANAGER

Responsibilities:

Led requirements, design, POC build, and Test phases on-time and under budget for pharmacovigilance system implementation

We provide IT Staff Augmentation Services!

Manager, Solution Delivery And Integration Resume

Lake Forest, IL

We'd love your feedback!

Resume Categories

Client Services

Job Seekers

Visa Sponsorship