Tamara Gebhart Email & Phone Number

Tandil, Ar

Remote

Greater Buenos Aires, Argentina

Manages the Sponsor Contracts Management team and activities, which support execution of procedures relating to the budgeting, preparation and management of contract and change order documents and any other associated duties as assigned. Assists senior management in the development, implementation, and maintenance of contracting processes and systems, while accurately capturing and reporting performance metrics on cycle times, quality, and other key performance indicators. Provides training and supervises contracts team.Line management responsibilities including professional development, performance appraisals, employee counseling for junior, and management staff, rewarding and disciplining. Assigns project work and reviews workload for all direct reports. Manages staff by establishing goals that will increase knowledge and skill level, and by delegating tasks commensurate with skill level.

Greater Buenos Aires, Argentina

- Primary customer interface on large, complex contracts, responsible for developing and maintaining customer relationships.- Revise or develop the contracts and related budgets and oversee finalization and distribution of documents.- Assist in the negotiation and provide advice, support and guidance to other Contract Analysts- Represent Contracts team at customer meetings and on task forces as required- Create budget, scopes and contracts as required- Mentor and train team members

Buenos Aires, Argentina

Contracts: Oversee the end-to-end contract creation and review process.Provide support on contract negotiations (including commercial and financial matters) with all stakeholders.Assess and analyze any request of changes to contract language to determine the associated risk level for the Company.Manage and maintain document templates and processes.Share best practices, develop strategies and recommend opportunities for continuous process improvement.Act as mentor and responsible for contract process training to relevant stake holders.Oversee metrics related to contracts review and negotiation process.FMV Latam Champion:Provide support during budget negotiations to ensure adherence to Roche's Compliance Policy on Fair Market Value, The US Federal Anti-Kickback Statute, and any local or international regulations regarding payments to Health Care Professionals.Act as regional representative, coordinating the work of the local FMV representatives in each Latin American Country.Ensure FMV representatives adherence to Roche's FMV Policy.Create awareness/acceptance of the definition of FMV.Systematically simplify and align the end-to-end FMV process: - Create 1 process for insourced/outsourced studies - Clarify roles & accountabilities - Specify criteria for appropriate documentation - Manage repository for site budget negotiation - Develop Key Performance Indicators (KPI’s) to monitor process performance - Apply the Lean Six Sigma Methodology known as DMAIC to improve the FMV process.

Buenos Aires, Argentina

To manage day to day work flow in the collection and review of legal and regulatory documents.Protocol regulatory y legal related documents customization and review, in accordance with GCP-ICH Guidelines and MoH/IEC requirements (Argentina, Uruguay)To act as primary contact with investigative sites during site start-up activities.To maintain up to date knowledge, ensure adherence and compliance with local (Argentina and Uruguay) regulatory requirements.To work with staff in Operational Strategy & Planning, Business Development and Operations, to provide legal and regulatory support.To ensure that all start up information and requirements are kept up to date in a central repository for project teams

Argentina

Lead the delivery of site activation of allocated studies within region to agreed timelines and budget.Day to day supervision of Start-Up assigned Staff to meet project objectives across multiple countries/ sites within the region; this includes but is not limited to prioritization of workload, reviewing document collection progress, addressing study specific questions, training and mentoring.Assess impact of project scope and / or timeline changes on resource requirements and work flow priorities within the region.Provide regional input in to study plans.Oversee the negotiation process of budgets, contracts, confidentiality agreements and site selection questionnaires and its adherence to agreed timelines.Set up and lead regional start-up team meetings and trainings as appropriate.Support new staff in region and integrate them into the study process efficiently.

Ensure quality training for the Document Specialists/Coordinators using appropriate training modules and monitor performance against training.Work in collaboration with Clinical Trial Manager (CTM) to determine resolution to issues in legal and regulatory documentation.Manage the Coordinator/Specialist work and track developmental progress.Conduct document verification in EDMS and handle the disposition of verified documents appropriately.Perform Quality Review on legal/regulatory documents. Notify Manager of any recurring inconsistencies to ensure corrective actions.Provide legal expertise on a specific therapeutic area in collaboration with the CTM and Medical Research.Conduct Quality Control of documents reviewed and processed by the Coordinators and Specialists, identify continuing process improvements for the therapeutic area and implement these changes in conjunction with the Director as appropriate across all therapeutic areas.

To collect, review and track regulatory documents from clinical sites, and to ensure their adherence to relevant Company Standard Operating Procedures (SOPs), Sponsors SOPs, FDA, EMEA, ICH-GCP guidelines and local regulatory guidelines.To set up and submit for approval MoH and Ethics Committees dossiers. To contact the Regulatory Authorities and Committees for study status follow-up.

To provide administrative and Project Management support to Functional Leads and Project Managers, ensuring consistency in standards of, and recommending improvements to, existing processes. Be the primary point of contact during absence of the Functional Lead. Review administrative requirements for client and internal kick off meetings. Setting up and maintaining the Central File.

To fully assist the Senior Director of the Firm, both legal and administratively. To perform research of legal documents, drafting contracts, mortages, separation agreements and trust instruments, to help prepare legal arguments, draft pleadings and motions, to investigate cases, locating witnesses, to obtain affidavits, provide trial assistance an organize and keep tracking of case files.I single handled the reconstruction and organization of the study file which included over 700 cases.

Lawyer, Law

Activities and Societies: Universidad de Buenos Aires, Buenos Aires, Argentina, Professor’s Assistant, Derecho Procesal Civil y Comercial.

Bachelor Of Commerce (B.Com.), Accounting And Business/Management