Financial Management Clinical Trial

EMINE MUTAF

CANDIDATE SUMMARY:

●Accomplished Contract, Sourcing and Procurement professional with Extensive Experience in the Healthcare, IT and Pharmaceutical Industry

●Experience in vendor evaluation and selection, contract negotiation and maintenance, and financial management processes in support of clinical studies.

●Experience in reading and developing responses to SOW, RFP, RFO, RFQ, RFI and other proposals.

●Responsible for the administration of Bids, RFPs and Pricing. Bid / Proposal coordination and scheduling, processing, response, including obtaining required approvals and responding to terms and conditions. Experienced in cost type, firm fixed price and T and M subcontracts and able to read.

●Proficient in managing Drug life cycle Phase I – Phase 4 and Clinical trial outsourcing for the Clinical Development programs.

●Designed and analyzed reports based on the collection of data related to the sourcing, contracting, management and performance of suppliers and vendors. Provided vendor onboarding. Used Ariba as the ERP system.

●Generated, reviewed and provided comments on procurement packages to include: RFQ, RFI, RFP, Performance Work Statements (PWS), change requests for both negotiated competitive procurements and sole source procurements.

●Indiect procurement categories: Marketing related services, professiomal services, travel amd travel management services,IT related ser vices, HR related services,facilities managementand office services,utilities, consumables, MRO, capital goods, fleet management

●Initiated, reviewed and negotiated contracts (NDAs/MSAs/EULAs) and consult with sourcing manager and/or legal as needed.

●Experience interacting with a wide range of suppliers (e.g., Contract Research Organizations (CROs, Cooperative groups, and Clinical laboratories, Core laboratories including ECG and Imaging service providers): initiating, negotiating and executing legal and/or financial agreements in the clinical trials environment- biotech or pharmaceutical industry.

●Managed supplier qualification, RFP, supplier selection, contract development, implementation, compliance, and ongoing supply base management process related to software and professional services.

●Reviewed buying trends for budget forecasts, provided metrics reports.

●Evaluate and monitor supplier performance and availability of services against SLAs.

●Provide communications and KPI metrics to leadership.

●Areas of focus include supplier evaluation, risk management and contract writing, negotiation and implementation.

●Resume summary align this for contract and sourcing Associate in bullets don't change the context but make first line attractive

PROFESSIONAL EXPERIENCE:

L3 HARRIS TECHNOLOGIES- SEABED SYSTEMS, San Diego, CA September 2023 to June 2024

Procurement / Supply Chain Specialist

●As an IT procurement manager created clear and explicit needs for IT products and services

●Track cost savings

●Transact the procurement requirements of multiple projects, establishing critical priorities and expediting related deliveries in a dynamic business environment

●Responsible to procure and manage assigned commodities to enable L3 Harris production. Which includes purchase order issuance and maintenance, administration of engineering changes, costing and cost project administration and purchased material cost analysis

●Creating PO package with all required documentation; i.e., Price Analysis, Justification Worksheet, Order acknowledgement, PPV, Excess, etc.

●Lead supplier negotiations and the supplier selection process

●Identify and implement cost reduction opportunities, as well as overall material cost control

●Managing supplier relationships of those commodities assigned, and assist in the development and implementation of supplier base strategies

●Resolving supplier base problems, including negotiations on Non-Conformances, invoicing, receipt discrepancy, terms and conditions, and service levels

●Providing training, guidance and coaching Procurement Agents in non-supervisory role

●Assist with Marketing requests including running Price Models to determine material costs for a proposed project

●Control and manage the inventory integrity of purchased items in the MRP data base associated with the commodities

●Provide guidance to the company on key events in the selected commodities that may effect the business plans of the company

●Maintain documentation control in compliance with FAR regulations and company procedures and policies

INSMED, INC., San Diego, CA May 2022 to June 2023

Clinical Procurement Manager

●Responsible for project management, Planning forecasting, scheduling, coordination resulting in the timely availability and allocation of drug supplies and to clinical sites and depots.

●Manage timeline and provide study progress reports to stakeholders.

●Enter and review purchase requisitions for goods and services to ensure compliance with prescribed purchasing and contracting policies and procedures. Facilitate supplier onboarding process.

●Interact with the Legal, Finance, and other departments, as needed, to ensure cross-departmental alignment with respect to processes and policies for contract development, approval, execution, and management.

●Interpret and communicate purchasing procedures to functions and provide purchasing support.

●Review commercial contract terms in accordance with company policy while meeting business objectives and achieving overall cost-effectiveness.

●Monitored supplier performance, billing validation, and contract terms. Negotiate pricing, and contracts with suppliers.

●Resolve purchasing problems between businesses and suppliers.

●Review Master Services, Confidentiality, Service standards, and other supplier agreements for compliance with company policies and guidelines.

●Manage changes in contract scope, change orders, and amendments to ensure accurate and timely revisions to terms and/or services and existing purchase orders.

ILLUMINA, San Diego, CA October 2021 to April 2022

Strategic Sourcing Specialist

●Managed Durg life cycle Phase I – Phase 4 and Clinical trial outsourcing for the Clinical Development programs. I was responsible for vendor evaluation and selection, contract negotiation and maintenance, and financial management processes in support of the clinical studies.

●As a sole Sourcing Specialist, was responsible for design, implementation and ongoing improvement of strategic sourcing for IT category

●This role is responsible for commercial relationship development and maintenance with suppliers within assigned categories.

●Will be responsible for supplier negotiation, discussions and escalations. Additionally, this position will be responsible for facilitating all communications, both internally and externally, regarding supplier pricing and commercial relationship status.

●This position will regularly work across functions and at all levels within the Organization.

●Must have strong negotiation skills and be focused on delivering savings, efficiency and de-risking of the end-to-end supply chain.

●Drive escalations for supply shortages and/or outages.

●Lead negotiation of commercial terms (with appropriate legal support) with suppliers to ensure that commercial risk is managed appropriately.

●Responsible for tracking and reporting vendor performance to Executive Team through KPI Dashboards.

●Facilitate execution of contract preparation and collaborates with product owners and sourcing managers.

●Accountable for complete management of SOW’s.

●Worked on clinical contract negotiations for savings, better value and quality.

●Identify and deliver direct spend savings to realize the performance objectives of the business.

●Deliver management information, reporting, insight and analytics on supplier cost and performance.

●Act as an interface between the supplier base and the NPI sourcing and engineering teams at Illumina.

●Resolves and/or direct the resolution of highly complex or unusual business challenges.

●Influences clinical and development timelines, study design and country selection. Directly responsible for reviewing and providing input to draft clinical protocols, communicating timelines and investigational product strategies to study and cross-functional teams.

●Participates in development, review and approval of Interactive Response Technology (IRT) specifications. Develops investigational product distribution strategies and maintains distribution and supply strategies at depot and site level according to study and IRT requirements.

●Actively participates in internal Trial Supply Management and Clinical Supply Chain meetings, Study Team meetings, Clinical Supply Matrix Team meetings and any other relevant meetings providing all relevant data and documentation prior to each meeting, highlighting any risks and mitigation strategies.

QUIDEL, San Diego, CA March 2021 to July 2021

Sr. Contracts & Sourcing Specialist

●Responsible for the development and implementation of the global commodity sourcing strategy for Quidel products.

●Supported supplier relationship & supplier performance initiatives.

●Insights were provided related to KPI’s (Key Process Indicators), reported to management and standardized business metrics.

●This role has the ability to work independently, effectively lead and work within diverse multi-functional teams, using deep knowledge of commodities and an understanding of technical requirements.

●This role provides expertise in the procurement elements of global commodity sourcing.

●Areas of focus include supplier evaluation, risk management and contract writing, negotiation and implementation.

●Responsible for delivering Clinical documentation.

SONY May 2020 to October 2020

IT Procurement Manager

●Managed the project by Establishing and managing relationships with internal customers/stakeholders.

●Supporting IT initiatives by understanding all processes and stakeholders within the IT group.

●Supporting Infrastructure Outsourcing and IT consulting Service Agreements/Contracts. I worked with sourcing and contract management of SAAS, IAAS, PAAS and especially focused on InfoSec and Data Privacy

●Initiating, reviewing and negotiating contracts (NDAs/MSAs/EULAs) and consult with sourcing manager and/or legal as needed.

●Assess contractor performance to identify the need for amendments of existing contracts.

●Negotiate contract agreements for products and services.

●Do web lining.

●Track and ensure that all contractual obligations (e.g., commitment dates, milestones, notices, renewals, and deliverables) are met.

●Serve as the main liaison with outside contracting representatives.

●Coordinate with clients to guarantee terms of contracts are fulfilled in compliance with the contract terms and regulations.

●Improve contract management process by developing standardized policies, tools, or processes and implementing in operations.

THERMO FISHER SCIENTIFIC April 2019 to December 2019

Sr. Category Leader

●IT sourcing interface with all Thermo Fisher divisions ensuring alignment of strategies and commitments.

●Implement and support the company’s IT Strategy and Plan objectives, timelines, and goals.

●Align the Strategic sourcing plans to enable IT investments and operations.

●Analyze cross-divisional spend to reduce total cost of ownership.

●Have worked with IoT in different capacities.

●As a category manager, worked with sourcing and contract management of SAAS, IAAS, and PAAS and especially focused on InfoSec and Data Privacy. I was also responsible for budget management, forecasts and spend analysis.

●Demonstrate a measurable reduction in year over year total cost of ownership for the goods and/or services being sourced without compromising quality and/or service levels.

●Also carried out corporate procurement responsibilities.

●Provide thought leadership in developing and implementing sourcing strategies.

●Create subcategory strategies using cross functional teams and sourcing process diligence.

●Manage contracting process and lead coordination with Legal to ensure commercial relationships are appropriately documented.

●Utilize and champion Ariba, eSourcing, Spend Visibility, and P2P tools company-wide.

●Experience interacting with a wide range of suppliers (e.g., Contract Research Organizations, Cooperative groups, and Clinical laboratories, Core laboratories including ECG and Imaging service providers): initiating, negotiating and executing legal and/or financial agreements in the clinical trials environment- biotech or pharmaceutical industry.

●Manage the supplier qualification, RFP, supplier selection, contract development, implementation, compliance, and ongoing supply base management process related to software and professional services.

●Manage relationships with the IT stakeholders and the suppliers.

●Experience in Quotations, Contract Management and Supplier Data.

SDG&E May 2018 to November 2018

Proposal and Contract Agent III in Technology

●Designed and analyzed reports based on the collection of data related to the sourcing, contracting, management and performance of suppliers and vendors. Provided vendor onboarding. Used Ariba as the ERP system.

●Create contracts and execute contract related activities including agreement change orders.

●Assist client in developing requirements and scope of work documentation.

●Negotiate purchase agreements. Coordinate with Strategic Contracting, Vendor Management, Finance and HR

●Periodic and ongoing vendor evaluation develops SLAs and metrics.

●Negotiate site budgets from base budget and payment milestones using appropriate guidelines; Escalate contract and budget issues as appropriate.

●Coordinate the corporate procurement proposal process, preparing the actual proposals and presenting them to clients. Work on tight deadlines. Focused mainly on IT proposals.

●Have experience in reading and developing responses to SOW, RFP, RFO, RFQ, RFI and other proposals.

●Worked with teams across the board to gather information, analyze relevant data and develop proposals that generate orders.

●Worked with project teams to review and determine requirements for proposals, collaborate with subject matter experts, and business development to define win strategies.

●Provide consulting and transition support for new engagements.

●Involved with improvement and innovation.

●Take initiatives, lead and mentors the contract management team. Tracks and reports metrics.

●Work closely with internal support organizations including Law Department, Accounts Payable, and Risk Management.

●Ensure client compliance with appropriate procurement, ethical behavior, and accounting policies.

●Maintain records to demonstrate that proper protocol was followed in the sourcing and contracting processes.

BOEING February 2018 to April 2018

Senior Subcontracts Administrator

●DoD subcontract management experience includes comprehensive experience in FAR/DFARS and mandatory flow down clauses, Cost Accounting Standards (CAS), procurement integrity requirements, contract law, contract formation and subcontract administration, cost and price analysis, negotiation, acquisition planning, supplier relationship management and project management.

●Hired on a contract basis by Boeing-Tapestry Solutions to help with the DCMA-Defense Contract Management Agency-, the Subcontracts &Small Business Utilizations audit which we passed with great success.

●Demonstrated experience soliciting and analyzing quotations, including SOW development; negotiating terms and conditions of purchase, payment, and price; thorough understanding of Patent and Data Rights Clauses.

●Work with internal customers and vendors to resolve problems.

●Exhibit leadership and teamwork and demonstrate the ability to build positive and professional relationships to successfully accomplish work assignments.

●Experience in evaluating, negotiating, pricing and administrating complex/high dollar cost reimbursement, fixed price and incentive subcontracts.

INTUIT July 2017 to December 2017

Sr. Technology Sourcing Specialist

●Sourcing/procurement skills related to technology sourcing, renewals, amendments, contract management.

●Experienced negotiator. Special emphasis on a "partnering approach”; able to reach mutually beneficial agreements that result in great outcomes for customers, shareholders, and the employees involved.

●Good communicator (written and verbal). Able to understand and communicate complex topics with simplicity across organizational boundaries and up/down the management chain.

●Worked with sourcing and contract management of SAAS, IAAS, and PAAS and especially focused on InfoSec and Data Privacy.

●Business acumen. Able to make decisions in an ambiguous environment. Willingness to take measured risks and to own outcomes. Adaptability, understanding of businesses. Able to quickly grasp and prioritize projects of importance strategy & business.

●Worked with Small-Medium budgets and processed multiple Purchase Orders daily. Also worked on corporate procurement items.

●Sourced from Asian markets, familiar with the processes, regulations, challenges, and benefits.

●Passion for learning and experimentation. Courage to team with others to solve problems and to lead critical thinking.

●Alliance builder. Able to build and maintain the trust of others. Impeccable integrity. Honors commitments and exceeds expectations. Able to establish and maintain valuable and genuine business relationships.

●Regularly monitors the quality and service levels of suppliers, to ensure excellent customer satisfaction and cost effectiveness.

●Consistently apply Supplier Relationship Management (SRM) best practices. Provided vendor onboarding.

●Regularly monitors the industry for opportunities to take advantage of status/changes.

●Meets Procurement, SOX, and other company policies and requirements; applies due diligence and compliance guidelines.

NOVARTIS, San Diego, CA October 2015 to January 2016

Sourcing Specialist

●Procurement of materials, supplies, equipment, tools required by scientists to carry on their experiments. In charge of RMA’s, CERF’s and CRAF’s. Also, in charge of drafting contracts, knowledge of legal t &c’s. Drafted Master Service Level Agreements. Knowledge of government contracts, FAR, DFAR, SOX, etc.

●Purchased assets and parts, conducted invoice reconciliation, updated the price lists in SAP, and managed the priority shipments that were on backorder.

●Responsible for vendor selection, sourcing, negotiating delivery terms, etc.

●Knowledge of Primary and Secondary Packaging -e.g. Bags, Vials, filters, and production supplies. Immunoassay, reagents, omni flex stoppers, neo flex plungers, duracoat combo seals, prime cap, e.g. Pills and tablet blisters, ampoules, syringes, stick packs and sachets, dosing dropper bottles, etc.

●Constant communication with both internal and external stakeholders.

●Provided supplier onboarding and performance evaluation. Proposal of ideas to Procurement and management teams monitored purchasing activities. Actively participated in implementing and maintaining Discovery Sciences' outsourcing strategy.

●Built and maintained an optimized partnership and close collaboration with business partners at every step of the end- to-end contracting process.

IBM, SIEMENS May 2010 to September 2012

Project Coordinator

●Worked in the conversion and integration of IBM and Siemens’ telephony systems.

●Effectively managed Field Operations capital and expense projects. Ensured adherences to quality standards and reviewed program/project deliverables. Planned material requirements using company's ERP system.

●Purchased raw materials, components and services at the lowest possible cost with acceptable standards of quality and service within established time frames. Investigated suppliers to establish their ability as a source of supply and maintained competitive sources of supply for materials, components, services. Reviewed components /services for possible in-sourcing or resourcing. Purchased MRO items, Capital and tooling requirements.

●Adhered to purchasing policies and procedures through review of requisitions within electronic procurement system, ensuring compliance with approvals, budgeting codes, international requirements and controlled substance regulations. Saved 40% on procurement of raw materials, components, parts, subcontractors and outsourcing.

●Obtained quotations and assists in evaluating potential new vendors and product sources. Communicated with researchers and vendors to accommodate requests for repairs and service. Verified all documentation related to goods received and work produced by additional procurement and receiving staff, and assists with resolving inconsistencies or issues within the supply chain.

●Possess knowledge of change management principles, experience using learning management systems

●Maintained and implemented a Move Process to enable a smooth and efficient move for all parties involved.

●Maintained building database accuracy and provide reports, manage equipment location and data, evaluation and assessment of space utilization and optimization and oversee reconfiguration of space, areas and furnishings to accommodate changing departmental and personnel requirements.

CARDINAL HEALTH, San Diego, CA April 2006 to May 2007

RFP & Bid Manager

●Worked as an SAP consultant for Cardinal Health in setting up their system in SAP for accounting, procurement, finance, contracts, pricing. Used metric reporting and equipment forecasting tools.

●Responsible for the administration of Bids, RFPs and Pricing. Bid / Proposal coordination and scheduling, processing, response, including obtaining required approvals and responding to terms and conditions. Experienced in cost type, firm fixed price and T and M subcontracts and able to read.

●Earned Value Management and interpret Cost Performance Reports.

●Experience in creating and managing acquisition plans, statements of work, synopses, solicitations, pre-negotiation and price negotiation memorandums, past performance verifications, subcontracting plans, purchase orders, award modifications.

●Generate, review and provide comments on procurement packages to include: RFQ, RFI, RFP, Performance Work Statements (PWS), change requests for both negotiated competitive procurements and sole source procurements.

●Accomplished goals through effective matrix-management across multiple functional areas including Engineering, Product Management, Pricing, Finance, Market Research, Marketing Communications, Sales, Training, Contracts, and Legal.

EDUCATION:

National University, San Diego, CA

Master of Business Administration, International Business, 3.9 GPA

University, Istanbul, Turkey

Bachelor of Science in Economics, Bogazici

CERTIFICATION:

●CPM, Certificate in Project Management, National University, San Diego, CA

SKILLS:

●Vendor Management/Project management

●Procurement, sourcing, outsourcing, negotiation, cost reduction, KPI metrics

●Sourcing and contract management of SAAS, IAAS, PAAS

●Client & Vendor Relations

●Computer Applications: MS Office, MS Word, WordPerfect, ACT, MS Publisher, Access, MS Project, AutoCAD, PowerPoint, Excel, Eudora, Ariba, SAP, MS Outlook, File Maker Pro, MS SharePoint, PeopleSoft, Peachtree, Google Suite, Smart Sheet, Agile environment, Teams, Novatus, Conga, RingCentral, LN 10.2, LN 10.5

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