• Partner with business teams to evolve and execute contracting strategy.• Drive the contract management process: draft, negotiate, and execute language and budget terms to ensure. consistency with Gore’s business and legal requirements within the U.S. and abroad.• Serve as primary liaison with site contracting representatives and drive site start-up as you coordinate, administer and monitor contracts through execution within business timelines.• Coordinate with and advise internal clients on various contractual provisions and issues and communicates information to stakeholders about contract-related matters.• Seek legal and/or regulatory advice when needed to assist in contract execution and negotiation.• Monitor and track active agreements.• Compile and analyze contract data and establish contract metrics.• When appropriate, provide input into process improvements for the management of executed contracts and templates.• Provide input and guidance to Clinical Affairs and other functions on initiatives, goals, policies, and procedures relating to clinical contracting activities.• Interact and collaborate with Clinical Affairs, Regulatory, Finance, Compliance, and attorneys to ensure timely and accurate contract preparation and problem resolution.

• Aids in the preparation of contractual provisions and the administration of contract proposals. • Responsible for preparing bids and negotiating specifications and contractual provisions. • Requires a bachelor's degree and at least 6-8 years of experience in the field or in a related area. • Familiar with standard concepts, practices, and procedures within a particular field. • Relies on experience and judgment to plan and accomplish goals. Performs a variety of complex tasks. • Works under general supervision; typically reports to a manager.

• Implement the coordination and management of outsourced contracting activities, and act as a primary point of contact for problem solving and escalation for assigned projects.• Creates and maintains an ongoing positive, collaborative and customer service driven relationship with administrators, external vendors and internal business partners. Proactively determines the potential need for contracts, including contract amendments with direction from the Senior Director, Contracts Management and Outsourcing as needed.• Assure that contractual terms and provisions comply with legal counsel guidelines, corporate processes, systems, and strategies and in accordance with industry standards.• Independently performs contract reviews and negotiations for multiple complex contracts, often utilizing external legal counsel as needed, as directed by the Senior Director, Contracts Management and Outsourcing.• Perform special projects as identified by executive management or business needs.• Provide central oversight and training of the Contracts Administration Database to include assignment of tasks and assisting with maintaining the integrity of the system.• Contribute to improving processes and establishing refinements that reduce cycle time and improve efficiency in the initiation of clinical trial sites.• Collaborate with other members of the Contracts Management and Outsourcing team to ensure proper dissemination and management of knowledge and to meet team goals and objectives.• Train other group members on group/departmental processes and operational activities• Supports study teams in the RFP process, selection of vendors, and management of vendor contracts.• Uses broad expertise or unique knowledge and skills to contribute to the development of company objectives and principles and to achieve goals in creative and effective ways.• Identifies and implements methods, techniques, procedures and evaluation criteria for assigned projects to achieve results.

• Drafted, reviewed, and negotiated complex and/or non-standard commercial contracts from initiation to execution (e.g., CDAs, MTAs, CSAs, Proposals, MSAs, etc.) reporting to Executive Leadership, Head of Legal and Contracts. Responsible for harmonization across multiple global Affiliates including various portfolio companies.• Supported across Commercial Manufacturing, Immunology, Innovation and Translation Business Units, providing essential stakeholder support to: Business Development, Project Management, Procurement, Facilities and HR departments and leadership to design and implement commercial contracting improvements across the entire corporate organization (i.e., LOI, Consent and Release Form, Contract Repository, etc.)• Provided strategic contractual guidance and risk management monitoring and insight to technical staff, project managers and executive management on contractual terms and conditions, and provided risk management advice pertaining to contract terms to minimize risks.• Developed and maintained dynamic, customer-centric relationships with internal stakeholders and external clients to efficiently execute contracts in a timely fashion.• Designed and administered commercial contracting policies, controls and procedures in accordance with stated corporate objectives and requirements.• Ensured that performance standards were met, and all contractual milestones and tasks were being executed in accordance with client expectations.• Created and developed a new contracting repository system to ensure compliance with contractual obligations and regulatory compliance.• Ensured that appropriate contract information was recorded in a timely and accurately within CostPoint (the financial management system).

• Ensures the successful negotiation and on-going management of clinical trial agreements with investigative sites.• Works cross functionally with Clinical Operations and Project Management in support of timely site start up for the conduct of clinical trials including accurate forecast of contract execution timelines.• Collaborates with the sponsor LM who will partner with other compliance departments to ensure country specific laws and regulations are followed to minimize risk in clinical trials.• Communicates and explains legal/ budgetary issues to internal and external parties per department guidelines.• Reviews and evaluates client requested contract changes and based upon department guidelines escalates deviations as appropriate.• Evaluates priorities and quickly readjusts priorities with the changing needs of business.• Identifies and proactively raises issues prior to their becoming critical or creates risk.• Appraises contracts for completeness and accuracy and ensures adherence to department guidelines; corrects documents and files changes to contracts.• Participates in local study team meetings for the purpose of expediting the contract signing process as directed.• Creates and maintains files for each contract.• Tracks all site interaction in data base in a timely and accurate manner and ensures that status updates are fully descriptive.• Generates ideas and solutions to improve requested contract/budget changes while appropriately partnering with sponsor LM for feedback and execution.• Advances consistency, timeliness and completeness of all interactions with site in database.• Exhibits increasing proficiency in executing documents that are complete and accurate delivered within shorter timeframes.• Exhibits proficiency in managing multiple projects with competing priorities.

• Managed assigned contract management processes, including but not limited to the coordination and finalization of contract instrument terms and budgets.• Reviewed protocol/budget amendments to clinical trial contracts and billing related changes due to changes in scope (i.e., work orders (WOs); change orders (COs), etc.).• Negotiated and prepared R&D contracts, budgets, and related documents for participation in clinical trials.• Communicated and explained legal and budgetary issues to internal and external stakeholders per company and departmental guidelines.• Ensured R&D contractual terms were effectively transmitted to the Finance department.• Ensured all executed R&D contracts and amendments were properly recorded in the appropriate contract databases.

• Negotiated and administered industry sponsored clinical trials and pre/ post Federal grant award activities.• Reviewed clinical trial agreements, budget amendments, and vendor change orders (COs) when changes in scope occurred• Worked in conjunction with Finance to manage, track, and forecast vendor accruals and expenses for each accounting period, including preparing associated journal entries.• Reviewed contract and grant award terms and conditions to ensure the information is effectively transmitted into the Finance department databases.• Ensured all executed R&D contracts and amendments were properly recorded in the contract databases and other repositories.

• Prepared, negotiated and reviewed complex R&D contracts on behalf of the Contracts and Finance Department.• Provided contract management support for various Federal and industry sponsored contracts and related documents (i.e., work orders (WOs), change orders (COs), etc.) as either a Federal Prime contractor and/or in the capacity of a CRO on behalf of third-party beneficiaries.• Managed and tracked vendor accruals working closely with assigned vendors.• Managed assigned industry sponsored portfolios in accordance with sponsor requirements/instructions, company policies and procedures, and applicable laws.

• Prepared and negotiated contracts on behalf of R&D Legal department through close collaboration with clinical operations.• Interfaced with the Clinical R&D, Legal, and Finance departments regularly to resolve pending contract and budget issues (i.e., billing/invoicing queries, etc.) for seamless execution of clinical trial agreements and other outsourced vendor agreements.• Ensured timely execution of multiple agreements, including clinical trial (phase I-IV), master clinical trial, site letters of indemnification (LOI), informed consent, CRO (i3Research, ICON, and Quintiles), clinical laboratory, advisory, material transfer, license, confidentiality, consulting, and collaboration agreements in support of outsourced and in-house studies.• Coordinated with clinical teams to develop protocol level budgets, determined study start-up activities, processed budget amendments, and negotiated clinical site budgets.• Collaborated with the Procurement department during the Request for Information and Request for Proposal (RFI/RFP) process, ensuring alignment with company policy.• Safeguarded and updated the legal contract templates, such as the Sunshine Reporting Act in accordance with new laws and company policies.• Suggested process improvement initiatives while managing multiple projects, such as the contract management request system (cReq2), master clinical trial agreements, and master confidentiality agreements. • Provided operational efficiency as well as reduced contract cycle time by adhering to company policies and procedures for contract development and interactions with internal departments and external stakeholders.

• Prepared and negotiated contracts on behalf of R&D Legal department through close collaboration with clinical operations.• Interfaced with the Clinical R&D, Legal, and Finance departments regularly to resolve pending contract and budget issues (i.e., billing/invoicing queries, etc.) for seamless execution of clinical trial agreements and other outsourced vendor agreements.• Ensured timely execution of multiple agreements, including clinical trial (phase I-IV), master clinical trial, site letters of indemnification (LOI), informed consent, CRO (i3Research, ICON, and Quintiles), clinical laboratory, advisory, material transfer, license, confidentiality, consulting, and collaboration agreements in support of outsourced and in-house studies.• Coordinated with clinical teams to develop protocol level budgets, determined study start-up activities, processed budget amendments, and negotiated clinical site budgets.• Collaborated with the Procurement department during the Request for Information and Request for Proposal (RFI/RFP) process, ensuring alignment with company policy.• Safeguarded and updated the legal contract templates, such as the Sunshine Reporting Act in accordance with new laws and company policies.• Suggested process improvement initiatives while managing multiple projects, such as the contract management request system (cReq2), master clinical trial agreements, and master confidentiality agreements. • Provided operational efficiency as well as reduced contract cycle time by adhering to company policies and procedures for contract development and interactions with internal departments and external stakeholders.

I supported the clinical evidence generation team in managing the contracting process from the point of receipt until implementation. I started Amgen’s sponsored clinical trial agreements for assigned protocols. I bridged the communication gap between Legal, Accounts Payable (AP), Finance, Clinical Research Managers (CRMs), and Clinical Research Associates (CRAs). I used “Grant Plan” to establish and finalize clinical site budgets at fair market value (FMV). I thoroughly reviewed and prepared journal entries for AP for issuance of clinical site progress payments. I managed and updated payment data in the financial management database (JDE) as well as in the clinical research database (eClinical) systems to remain within budgetary constraints. I studied Contract Request Forms (CRFs) to check accuracy and completeness, also established new accounting records in the financial management system (JDE) for all executed clinical site contracts. I obtained internal signature approval for the clinical site contracts.My accomplishments in this job are listed below:⇨ Increased company’s financial liability of clinical site budgets for non-performing clinical sites by drafting clinical site amendments.⇨ Maximized knowledge of clinical research services department policies to forward accurate information.