Through coordination with Business Unit Liaisons and Business Unit Clinical Trial/Study Managers, conduct clinical trial site start-up activities related to the preparation of fair market value analyses and clinical study budgets in collaboration with BSC Legal.  Ensure consistency and compliance with service level agreements, legal and regulatory standards (ICH/GCP, FDA, IRB/EC, etc.) and applicable internal company policies & procedures (SOPs/WI).Work independently and proactively using the study protocol and fair market value databases to complete study specific budgets. Familiarity with diagnosis codes and medical coding practices.Manage large portfolio of budget related activities across several studies and division portfolios. Coordinate with the Business Unit Liaison and clinical study teams to continually prioritize budget reviews as new information and/or considerations are introduced to keep pace with overall service level targets. Provide updates to the BU Liaison with the purpose of informing the BU on overall study spend commitments.Develop and foster relationships to become a subject matter expert in the budget creation process.Maintain and stay current with divisional clinical study team priorities as applicable to active contracting and budget finalization timelines.  Ability to critically review budget negotiations with clinical research sites to authorize escalations outside of fair market value. Develop, prepare, complete and track required budget documentation.Update and maintain study-specific startup trackers as it relates to budget details.Oversee vendor KPI metrics on accuracy and timeliness of budget reconciliations and global spend transparency reporting.Update and maintain budget information in Clinical Trial Management Systems as required.Escalate risks and/or initiate outreach to SSU COE leadership, divisional clinical study leads and/or other stakeholders when appropriate.

Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. Provide support to the clinical team in the pricing, planning, execution and control of grants and contracts.Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator initiated studies through direct negotiation with clinical trial sites or via over site of a Clinical Research Organization responsible for contract negotiations. Responsible for analyzing contract requests/needs from operating companies and translating into appropriate contracts/budgets for company sponsored and investigator initiated clinical trial agreements and other relevant legal documents as they relate to various clinical projects. Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.Work with the global C&G team as necessary to review and analyze contractual terms and conditions in order to reach acceptable language. Assess risks of budget and legal provisions in conjunction with members of the C&G team and support functions and communicate such to stakeholders. Liaise with C&G management and functional C&G support teams, legal, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate. Assume responsibility for all aspects of legal document and metrics tracking. Determine potential needs for contract amendments and manage amendment life-cycle.Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites. Mentor and train new contract coordinators and analysts.

Creation & translation of labels, package inserts, image files, packaging Bills of Material and Packaging procedures based on instructions from Regulatory, Brand, Product Development and Packaging Development. Assist in all activities necessary to generate, revise, and assure the integrity of product labels and package inserts, domestic and foreign, for all products manufactured at Zimmer Biomet or products manufactured for Zimmer Biomet at External Alliance sitesCreate MCs for an internal review/approval of each separate POD IFU created/updated (for consistency of format, design, heading, footer, symbols, trademarks, tables, etc.); POD IFUs are posted and approved in Livelink workflowCreates Document Lookup Table xls to be loaded to Prisym in order to capture Item Number/IFU associations related to Eschbach Distribution Center LLL & FLL stations; includes but is not limited to creating Linking, Loading xls; includes WinterthurTraining of Labeling Group job functions, in order for temporary or contract personnel to understand and help the Labeling DepartmentPrint Label PDFs as needed, for other departments, other sites (Portugal), email inquiries, etc.Email inquiries pertaining to anything related to global packaging and labeling of Zimmer Biomet products or software. Provide necessary support or direct them to the appropriate packaging engineers

Member of the Zimmer UDI regulatory compliance team, ensuring data accuracy and cleansing for Class I and II devices prior to uploading into the GUDID database Collect & Evaluate FDA criteria for over 40,000 orthopedic part numbers (SKU’s)Cross reference extensive RA 510(k) data from one data source to anotherVerify premarket notification data from current submission to part numbersReview 510(k) numbers to all assigned part numbers to be submitted to the GUDIDConfirm entries in the data management system (Informatica MDM) for GUDID submissionsAssist in identifying and resolving gaps in current systemsVerification of product attribute information against business systems including: device class, product codes, premarket submission numbers & GMDN codesMaintain all applicable spreadsheets & scopesApprovals (Submissions) of Class II FDASIA UDI records to the GUDID database via the FDA’s web interfaceParticipate in improvement activities in support of the new Informatica MDM systemAssist in the alignment of internal databases’ records for completeness and accuracyAudit data in scopes for discrepancies and make recommendations for correctionsProvide timely status reporting and actively participate in programs status and planning meetings with project managersResponsible for successful execution of assigned project tasks based on Quality & Regulatory decisions within the UDI project teamAddress technical issues that arise during record submissions to the GUDID database and communicate/escalate as requiredAbility to work well and deliver under rigorous timelinesParticipate in ongoing meetings with work stream members. Address issues in meeting commitment schedules to achieve departmental and company goalsEnter data from case report forms into clinical databaseAssist in maintaining filing and retrieval of case report forms, correspondence, and other study related documents.

Responsible for reviewing, auditing and processing payroll and performing Human Resource functions. Hands-on involvement in the billing and cash receipt process including collections. Assist CEO in developing and improving business processes and internal procedures.Audit vouchers, invoices, contracts and agreements for accuracy and completeness. Oral & written communications in order to provide customer service support, instructions/guidance and resolving disputes with vendors. Utilize computer software and accounting information systems to process payments; and enter, modify, retrieve and/or delete accounting information.Manage cash balances and ensure timely deposits. Complete Monthly Bank Reconciliations. Oversee all inventory and job costing. Prepare all monthly and quarterly reports including 940, 941, WH-1 & UC-1. Ensure company accounting procedures conform to typical accounting principles.Prepare financial analysis for contract negotiations and product investment decisions. Ensure compliance with local, state, and federal reporting requirements. Prepare ST-105 Forms, Joint Payment Agreements & W-9s.Maintain all insurance bonding, license & certificates including group health, workers compensation, general liability, inland marine, property & automobile policies.Establish and implement short- and long-range departmental goals, objectives, policies, and operating procedures. Prepare profit and loss statements and monthly closing and cost accounting reports. Compile and analyze financial information to prepare entries to accounts, such as general ledger accounts, and document business transactions. Establish, maintain, and coordinate the implementation of accounting and accounting control procedures.

Interview prospective employees, complete all new hire paperwork & forms. Calculate weekly payroll hours and process payroll checks. Maintain all personnel files. Prepare all month end and quarterly tax reports including: 940s, UC-1, 941, Sales Tax & State and County forms.All data entry for daily service schedules. Dispatch incoming jobs to appropriate service technicians.Handle all insurance and bonding including: group health, business liabilities, workers compensation and vehicle insurance.Process daily bank deposits and month end bank reconciliations.Post all of the general ledger transaction and journal entries.Responsible for overseeing accounts receivable and collections process. Set up payment plans for self-pay accounts and monitor payment activity.Receive & process all sales orders. Invoicing of all customers, new account setup. Obtain credit information and post all incoming payments.Quote outgoing freight fees for all out of state customers. Schedule all inbound and outbound freight. Maintain daily shipping and receiving schedules for shipping dock.Accounts Payable, data entry for billing, processing checks to appropriate vendors & set up all new vendor accounts.Inventory Control, maintain purchase schedules, verify inventory variances, appoint inventory crews for month end physical inventory, maintain monthly inventory reportsPurchase all products, office supplies and materials needed to run the daily operations of the business.Customer service, inside sales & quoting for commercial, residential and industrial accounts.