Manager, Clinical Logistics Change Management
About The Position
The Manager of Clinical Logistics Change Management provides end‑to‑end coordination and oversight of clinical logistics change management to support study startup, product lifecycle activities, and operational readiness. It ensures alignment across cross‑functional teams (e.g., IT, ClinOps, ClinDev, CMC Reg, PQ, KCC, RDQ) to enable timely execution of new product introductions and study readiness. Key responsibilities include leading Investigational Product Manual (IPM) development, managing document change controls and revisions, and triaging broader change impacts across clinical logistics. The role ensures system readiness, and adherence to change timelines. Additionally, it drives transparency by tracking and communicating all change management activities impacting clinical logistics, ensuring stakeholders have clear visibility to progress, risks, and readiness milestones.
Requirements
- Bachelor's Degree and Six Years' Experience OR Masters' Degree and Four Years' Experience
- Experience in clinical logistics, clinical operations, or clinical supply chain within the biopharmaceutical industry.
- Experience executing and participating in cross functional change control management from inception to effectivity in the biopharmaceutical industry
- Strong understanding of end-to-end clinical trial operations, including patient specific logistics, global trial execution, and their impact on operations.
- Experience with ERP systems (EBS, SAP, etc.)
- Experience with DCS and QMS systems (Veeva, Agile, etc.)
- Experience with CRM software (Salesforce, Veeva, etc.)
- Experience with clinical trial tools and systems (CTMS, EDC, eTMF, IRT, IXRS, etc.)
- Knowledge of GCP, GMP, GxP, ICH principles and regulatory requirements.
- Excellent communication, collaboration, and stakeholder management skills.
- Strong planning and the ability to create structured, actionable, and adaptable roadmaps while anticipating obstacles
- Ability to collaborate across multiple functions.
- Ability to manage complexity and multiple priorities in a fast-paced environment.
- Proficiency with Microsoft Office, SharePoint, Smartsheet, Salesforce, ThoughtSpot, Spotfire, and other business systems
Nice To Haves
- Bachelor’s degree in Life Sciences, Supply Chain, Business, or related field preferred
Responsibilities
- Engages with GSC EXPAND, IT, and clinical logistics managers in Demand Planning and Systems (amongst others) to enable New Product Introduction (NPI) and Product Variation Management (PVM) Expansion
- Determines impact of study startup activities to clinical logistics by conferring with clinical logistics management
- Coordinates timely execution of change management tasks with impacted clinical logistics owners to ensure timely completion in line with established change control effective dates, and forecasted clinical trial readiness dates
- Works with IT to ensure ERP configuration and readiness to enable clinical logistics activities
- Works with Clinical Logistics Systems manager to ensure Salesforce cell journey orchestration platform configuration and readiness to enable clinical logistics activities
- Receives and triages clinical logistics impact assessments (IA) from across the org unrelated to study startup readiness
- Facilitates review with impacted subfunction/s within ClinLog to ensure timely and accurate IA submission and task completion
- Leads and manages IPM (pharmacy guide) development across all products
- Owns IPM related procedures and Center of Excellence (CoE) charter and meetings
- Engages key cross-functional IPM members and contributors in PD, CMC Reg, PQ, ClinOps, and ClinDev to ensure accuracy and compliance with study and product design
- Initiates document change controls in Kite’s DCS and coordinates document revisions with process owners in clinical logistics
- Ensures timely revision of documents by process owners in line with change management timelines and clinical trial readiness dates
- Engages RDQ and KCC to ensure adherence to document writing best practice, and compliance.
- Owns and maintains SOPs for change management (not inclusive of other clinical logistics functions)
- Owns internal training material for change management
- Tracks and provides visibility to all change management tasks impacting clinical logistics to management and department stakeholders via report and dashboard creation and maintenance
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
