Patrice Volensky
Quakertown
Summary
Strategic Supply and Logistics Project Manager with over a decade of experience enhancing operational efficiencies in pharmaceutical research. Expertise in budget management, revenue forecasting, and timely delivery of clinical supplies. Demonstrated success in multinational environments, ensuring project timelines and profitability align with contractual agreements.
Overview
18
18
years of professional experience
Work History
Supply and Logistics Project Manager
Parexel
02.2023 - Current
- Review and approve project scope, timelines, and budgets
- Identify and communicate deliverables to stakeholders
- Develop logistics concepts and solutions
- Balance study deliverables, objectives, and profitability
- Ensure study/project timelines and budgets are met in accordance with the contractual agreement including proactive management and communication of timeline changes to ensure the efficiencies are maximized.
- Ensure that study specific management tools and documents are in place and constantly maintained.
- Proactive management of timeline changes
- Maximize operational efficiencies
- Maintain study-specific management tools and documents
- Review and manage CTS&L FTE (Full-Time Equivalent) assignments
- Ensure appropriate staffing levels
- Initiate project-related training for team members
- Train CTS&L staff
- Review and approve project scope, timelines, and budget for the contract development. Identify and communicate project deliverables to all stakeholders.
- Engaging internal and external clients to develop logistics concepts and solutions to meet study deliverables, objectives and profitability while achieving client satisfaction.
- Ensures study/project timelines and budgets are met in accordance to the contract agreement
- Finance and Profitability Management (Monthly, control, input) incl. client invoicing
- Maintain Parexel’s Internal Project controlling/Financial systems including but not limited to monthly revenue and forecasting
- Pass Thru Cost (PTC) management with controls and reporting of costs for internal service fees and external providers incl. invoicing.
- Gather feedback and evaluate on the projects status and identify for any potential CIS (Change in Scope) for professional and/or PTC needed in a timely manner to ensure that the operational tasks are contractually covered
- Follow through on any CIS until signature.
- Monitors the projects status and identify for any potential Change in Scope (CIS) needed in a timely manner to ensure that the operational tasks are managed.
- Contributes to profitability/finance management (monthly reporting & forecasting, budget control, change in scope management
- Lead project meetings and support team members to monitor and ensure that projects are completed within budget, schedule and according to contract specifications in accordance to the quality standards, SOPs, ICH-GCP, GMP, GCLP, GDP and/or any other guidelines to fulfil local regulations, including customs regulations
- Support ongoing optimization of system infrastructure (systems used by CTS&L such as IPTrack, LoMAS, processes, other internal tools) Implement process improvements, including CAPA, in conjunction with the team, in response to corporate, quality issues, client and team feedback and quality audits.
- Prepare, represent CTS&L project team and follow up on audits/inspections
- Performs risk assessment and develops mitigation/contingency plans as needed and manages project execution accordingly.
- Ensure that study specific management tools and central file maintenance plan are in place.
- Initiate project related training for project team members and ensure project team members adheres to processes established
Protocol Project Manager
ICON (Merck)
Blue Bell
11.2021 - 02.2023
- Proactively obtain relevant protocol information to source supplies and determine a global distribution strategy
- Serves as a member of the Clinical Study Team
- Function as subject matter expert for customers throughout the organization on issues related to clinical ancillary supplies and project management
- Interface with preferred and third party vendors to source supplies and coordinate on time deliveries
- Coordinate and forecast ancillary supply delivery timelines with Clinical Team and CRO’s partner
- Maintain close communications with all internal customers to ensure the adequate supply of clinical ancillary supplies throughout the duration of a clinical trial
- Coordinate and run weekly therapeutic area review meetings to problem solve issues involving study status and changes
Ancillary Supplies Coordinator
ICON (Merck)
Blue Bell
07.2018 - 10.2021
- Uses SAP applications to forecast sites and monitor supply planning
- Manages clinical trial materials for the study
- Manage equipment reservation process and equipment lifecycle project
- Responsible for analyzing, planning, and sourcing ancillary supplies for Merck’s global clinical trials
- Coordinate initial, resupply, and return shipments within assigned protocols
- Run and review weekly reports for clinical trial enrollment, screening, and supply strategies
- Conduct weekly operations meeting with team members to forecast and plan shipments
- Monitor inventory level in inventory management system, and monitored/kept current equipment servicing
- Create a SASI for studies visibility into items going to sites
- Works with company clients, packaging sites, and depots to get shipments to sites by study start up date
- Manages Purchase orders needed for studies
Logistics Planner II
07.2016 - 06.2018
- CRD Team; Updating Proforma and Commercial Invoices
- Inventory Snapshot; Running inventory report two times per day. This allows the group to check inventory before doing shipments
- Made sure the team is up to date with GTT (Global Time Tracking). Send out reminders and receive reports about input of time worked
- Worked with the IQ Team to communicate training updates. Making sure new or updated training and supporting documents are uploaded to our shared drive. Communicating to the team when new trainings or processes have changed. Using Quickbase to enter in training credits
Logistics Planner I
11.2014 - 06.2016
- Country Requirements Database Import/Export compliance. Liaise with country contacts to ensure Country Requirements Database meets all international regulatory compliance standards.
- Maintain ASM’s (Ancillary Supply Management) library of Proforma/Commercial Invoices ensuring they accurately reflect international standards
- Created a three month forecast of all ASM shipments
- Created Proforma/Commercial invoices in accordance with Country Requirements Database ensuring import compliance for all ASM shipments
- Created and executed Purchase Orders in SAP SRM environment for Ancillary Materials
- Communicate with warehouse personnel and equipment vendors to ensure timely delivery of supplies
- Created and executed ship orders in Merck’s ERP system for clinical sites/Depots (Domestic & International)
- Created and execute returns related to Ancillary materials from Clinical sites in Merck’s ERP system
HR Coordinator
08.2007 - 11.2014
- Worked with Asia Pac, France, Spain, US office to update and distribute client information such as renewals, end notifications, changes in salary, and re-assignments
- Process and distribute ERF’s (Employee Record Form), reassignments, new employee information, amendments. Allows the company to see changes in any employee status
- Worked with Internal managers to complete ERF’s and ensure Employment Accuracy
- Daily tasks include creation, verification and distribution of all employee resource data globally
- Efficiently maintain information in the RPS Resourcing database, ensuring that all information is current and current and accurate, and is updated in real time; extrapolate and analyze required information from the database to create candidate, contact and company profiles, and job order
- Maintained spreadsheets and reports for analysis
- Maintained contact with all departments regarding RPS Resourcing database
Education
Undergraduate, Bachelor degree - Psychology
Temple University
Philadelphia, PennsylvaniaSkills
- Client focused approach
- Flexible attitude
- Ability to manage multiple tasks
- Prioritization
- Attention to detail
- Operational Leadership
- Project management
- Business acumen
- Consultative selling
- Negotiation
- Communication
- Customer management
- Leadership
- Interpersonal skills
- Mentoring
- Training
- Creative solutions
- Operational understanding of Clinical Studies
- Supply Chain knowledge
- Global team management
- Self-motivated
- Teamwork
- Proficient in MS Office suite
- Excellent verbal communication
- Excellent written communication
Timeline
Supply and Logistics Project Manager
Parexel
02.2023 - Current
Protocol Project Manager
ICON (Merck)
11.2021 - 02.2023
Ancillary Supplies Coordinator
ICON (Merck)
07.2018 - 10.2021
Logistics Planner II
07.2016 - 06.2018
Logistics Planner I
11.2014 - 06.2016
HR Coordinator
08.2007 - 11.2014
Undergraduate, Bachelor degree - Psychology
Temple University