Project Manager It

STANLEY A. HOLMES, PMP

Edison, NJ 732-***-**** *****************@*****.*** www.linkedin.com/in/stanley-holmes

PROJECT MANAGER

Project Manager IT & Compliance Agile & Waterfall Methodologies

Certified Project Manager (PMP) with extensive experience in leading complex IT and regulatory projects within the pharmaceutical and healthcare industries. Proven ability to optimize application landscapes, manage compliance assessments, and drive cross-functional collaborations. Adept at leading Agile and Waterfall projects, ensuring timely delivery, risk mitigation, and compliance with regulatory frameworks. Skilled in managing vendor relationships, IT risk assessments, and data security. Passionate about fostering diverse and inclusive work environments while driving business efficiencies.

Key Skills:

IT Project Management & PMO

Agile, Waterfall, and Hybrid Methodologies

Regulatory & Compliance (GxP, FDA, CAMPS)

Risk Management & Process Optimization

Vendor & Stakeholder Management

Data Governance & System Migrations

Workshop Facilitation & Team Leadership

PROFESSIONAL EXPERIENCE

BAYER, New Jersey August 2021– Current

Bayer, New Jersey (August 2021 – Present)

Associate Product Specialist IT Project Manager

Led an enterprise-wide IT application optimization project, successfully analyzing and rationalizing 49 applications—resulting in 21 replacements and 7 retirements, reducing system complexity and costs.

Managed Bayer’s Enterprise Architecture Tool, ensuring real-time updates and accuracy for application inventory.

Oversaw CAMPS (Compliance Assessment and Management Procedures), identifying IT risk factors and ensuring compliance with internal policies and external regulations (GDPR, FDA).

Facilitated cross-functional workshops across multiple time zones, driving inclusion and innovation through 15+ leadership sessions.

Organized & facilitated the Clinical Operations IT workshop in Germany, planning agendas, securing guest speakers, and leading collaboration efforts.

Short Term Assignment, October 2020 – May 2021

Coordinated the UAT testing activities for the Radiology Regulatory Information Management System, RIMS is utilizing the Kalypso’s Accel for Regulatory Information Management Solution (RIMS), an add-on module designed to enhance PTC Windchill PLM for supporting regulatory submissions. Kalypso Accel for RIMS provides a single, global source of truth for product registration planning and tracking with features that accelerate regulatory submissions. The PTC Windchill system manages product data and process-related information in a single, central system. Project was run using Agile methodology.

Assist scrum master for the PHAROS project. Support all process steps for planning and tracking of PV safety report generation (e.g. PBRER, DSUR, ACO, etc.) and risk management planning commitment tracking.

Replaced MS Access non-GxP system for tracking PV safety report generation Risk management SharePoint. Project done with Waterfall approach.

Stanley A. Holmes *****************@*****.*** 732-***-**** Page Two

Submission Assistant, June 2013 – August 2021

Received and documented all submissions attachments, (monograph product labels and literature) and preparing the documents for transmission through the FDA gateway.

Prepared attachments by combining into single documents altering document properties to make transmittable and identifiable to FDA.

Reviewed attachment submission acknowledgements for errors and resubmission. Filed receipts of successful transmission. Completed SUSAR submissions and send via email and UPS. Uploaded SUSAR submissions to ShareDoc. Created IND safety reports for Regulatory Affairs; updates information on excel spreadsheets.

Managed mailbox for GPV-US Submissions and responded as needed. Checked on various PADERS from submission team.

Pulled monograph certified art for Bayer label and carton products from SYNAPS database.

ADDITIONAL EXPERIENCE

Bayer - Safety Data Coordinator June 2007-2013

PharmaNet - Safety Associate II Database Administrator

PROFESSIONAL EDUCATION, TRAINING, CERTIFICATIONS

Bachelor of Science (BS), Computer Science Rowan University

Certified Project Manager Project Manager Institute

PM Master Prep Certification

Project Management Academy Certification

Project Management Certification Middlesex County College

Coursework in Computer Information Systems Strayer University

Web Page Design & UNIX Shell Programming Middlesex County College

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