Andre Raphino

Develop strong vendor and site relationships and ensures continuity of relationships through all phases of the trial

• Obtain and maintains in-depth understanding of the study protocol and related procedures in order to contribute strongly to study team knowledge by sharing best practices, making recommendation for continuous improvement and providing training as appropriate/required
• Coordinate & manage various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure
• Work with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
• Support financial management of the study which includes review and approval of the site and vendor invoices
• Support audit/inspection activities as needed
• Maintain clinical trial registry entry/updates, as required
• Work directly with TMF Content Owners to identify issues, perform completeness checks, and upload documents to the eTMF
• Review and classify documents collected from internal and external sources
• Perform data entry and reconciliation in various clinical systems and tracking tools
• Manage paper document filing process for wet-signed documents including QC review and paper/electronic filing
• Participate in audit, inspection readiness preparation and inspection activities as needed

• Manage the day-to-day activities of multiple areas in complex clinical contracts and finance processes
• Demonstrate strong understanding of regulatory and legal issues pertinent to the clinical development
• Provide input to strategy for and supports the implantation of Site Contracts strategy and the activities necessary for the development and execution of site contract for Amgen studies
• Focuses on site contracting, fair market value (FMV) compliance of site contracts, and financial accountability as it relates to FSP management
• Lead the escalations related to the site contracting and budget negotiations in terms of risk management, leading issue resolution at the operational and senior executive levels
• Train staff in contract budgeting, development, and administration
• Develop appropriate job aides and tracking tools
• Manage contract activities for multiple clinical development programs, ensuring that there is adequate staff with the skills to complete contracts accurately, consistently, and in a timely manner
• Demonstrate a basic understanding of the regulatory implications of contracts as related to clinical research – Good Clinical Practices (GCPs)
• Utilize prior experience in the development of, or reporting on, portfolio level Key Performance Indicators, and subsequently uses these to drive performance goals and improvements, as necessary
• Deliver with optimal collaboration, accountability, and integrity to business partners
• Show clear ability to apply critical thinking, strategy development, and vision towards the growth of the vendor relationship management program, while also overseeing the day-to-day execution in a high volume, fast paced environment
• Participate in establishing departmental and cross-functional policies and procedures
• Translate the usage of industry best practices to the overall program, utilizing external sources such as benchmarking, data, and processes to continually provide input and drive improvements linked to an overall strategy

• Oversee negotiation of CSA contracts, and Investigator Initiated Study Agreements and budgets with clinical research sites (including doctor’s offices, academic institutions and hospitals within the United States and Puerto Rico)
• Work under the guidance of Global Site Contracting and Contract Operations to draft and negotiate a limited number of agreement types, such as clinical study agreements and/or Investigator Initiated Study Agreements by the manager
• Assist in drafting and negotiating agreements that support Global Site Contracting and Contract Operations activities on time and within required budget parameters
• Economically and efficiently purchase services for R&D and GMA in compliance with Clinical Contracting and Purchasing Policies
• Perform contract support tasks such as SRM and contract execution and/or tracking activities in support of Clinical Contracting team members
• Responsible for identification and resolution of contract issues while working closely with therapeutic/functional areas, legal, OEC and suppliers
• Develop and maintain necessary contracting documentation according to departmental policies and procedures
• Provides contract status updates to therapeutic/functional areas and Global Site Contracting and Contract Operations contract management team
• Promote company as the partner of choice in all external communications and dealings to build the brand

• Assist in the development of investigator grant budgets according to protocol specifications
• Negotiate clinical study budgets and clinical trial agreements (CTAs) with investigators or designated site personnel
• Perform Coverage Analysis (CA) to ensure correct billing and maintain institution compliance standard
• Maintain a tracking system of all clinical study agreements, issues and communications with internal and external sources regarding contract and budget status
• Participate in clinical study team meetings, kick-off meetings, bid defense meetings and departmental/company meetings
• Develop relationships with Investigator Sites to facilitate effective communication and achieve favorable terms
• Provide input into contract template development
• Assist with the negotiation and finalization of other contract types as may be assigned, including but not limited to confidentiality agreements (CDAs) and vendor agreements

• Deliver investigator/institution research-related agreements
• Assist team members in the management of the outsourcing, vendor selection and clinical contracts process
• Negotiate and maintain clinical development contracts, including CDAs, MSAs, Clinical Trial Agreements, Work Orders, Consultant Agreements and specialty vendor contracts
• As required, oversee CRO or Functional Service Provider in the development of clinical site budgets and partner with clinical operations to ensure budgets are in line with study protocols
• Oversee CRO and Functional Service Provider activities in regards to site CDA’s and site contracts
• Negotiate clinical trial agreement language and budgets with sites using pre-defined negotiating parameters
• Ensure that site contracts are mutually beneficial contractual agreements for both sites and Sponsor
• Serve as primary site contracts lead person for studies
• Prepare and document process flows for each study; follows processes that may differ across studies
• Collaborate with other departments involved in study start-up activities to ensure timely initiation of sites
• Maintain and track communications with sites and internal staff
• Assist supervisor with managing and maintaining contract templates
• Perform other duties as assigned

• Manage all negotiation and finalization of all CTAs and service contracts with Legal Department, study team, Sponsors, and PI
• Managing the execution and/or amendment (including signatories) of contracts within both site and sponsor/CRO, investigators and third-party fiscal agents if applicable
• Reviewing study budgets and costs pertaining to contract negotiation
• Representation of the Company in relations with clinical sites, investigators, other parties and project-related vendors, as applicable
• Performing legal translation and/or proofreading of contracts with study team and investigators
• Develop, monitor, track and process new and amended investigator/site contracts and other project-related contracts
• Review contracts and other documents for completeness and accuracy
• Maintain and update hard-copy and electronic contract files
• CTMS & Data entry, maintenance and regular update as assigned

• Review of clinical trial protocols and develop internal budgets for presentation to principal investigators and CROs
• Manage pertinent Study information in Protocol module in CTMS application (Oncore, RealTime, & Medrio)
• Code each procedure per applicable CPT/HCPCS coding guidelines for FMV evaluation and revision
• Review Schedule of Assessments (SOA) activities to be performed during trial execution with the sites for roadmap and calendar of tests, measurements, and evaluations
• Perform accuracy review of contractual documents on a highly time-sensitive basis and coordinate clinical study billing application on a monthly basis
• Consistently maintain general knowledge of protocols and prepare amendments of budget and/or contracts as required by sponsors or as requested by principal investigators
• Build study templates in Clinical Trials Management System (Oncore, RealTime, & Medrio) and Multi-Site Portal with consistent oversight
• Complete monthly Product Line Assessments with each client and participate in special projects as requested
• Negotiate Master Service Agreements, amend budgets, payment schedules and other documents of contractual agreement specification
• Successfully manage $7M-10M in yearly receivables from sites
• Manage all aspects of clinical invoice processing and payments

• Responsible for growing a client portfolio that focuses mainly on Loans, FX, Derivatives, and Cash Management
• Manage client relationship through providing financial solutions to both individual clients and small businesses
• Focus on deepening customer relationships through the power of every connection and exceeding quarterly sales goals
• Create and maintain a pipeline of business banking sales opportunities/relationships through multiple prospecting/business development techniques
• Coach and develop team of personal bankers in execution of key plays while role modeling on a daily basis
• Consistently drive individual and team success through data/reports analysis, while deliver value added experience to clients
• Effectively monitor and manage risk through Code of Ethics and Compliance adherence while also leverage available tools and knowledge
• Engaging in weekly proactive planning sessions for client engagement activities while promoting responsible growth culture

• Supervise and coordinate activities of all personnel engaged in daily security operation
• Ensure adherence to Harvard University quality standards and client specifications
• Interface on problem resolution, corrective action implementation, including employee training
• Engage in and/or arrange for all security personnel for necessary certification
• Assist in consistently promoting students focused environment through leadership and example
• Conduct regulatory inspections/investigations and supports criminal investigations related to alleged or suspected security violations
• Provide overt and covert presence, including at high visibility activities, to detect and reduce identified security threats/vulnerabilities
• Assist in formulating recommended or alternative courses of action pursuit by regulated parties in order to satisfy security requirements

• Identify prospective customers using established lead methods
• Conduct information-gathering meetings with clients
• Analyze client needs and presenting potential solutions
• Sell life and other insurance products to individuals within assigned territory using consultative selling techniques
• Advise policyholders on matters of protection and coverage
• Participate in various incentive programs and contests designed to support achievement of production goals
• Develop and implementing personal business and marketing plans
• Meet goals for volume of quality new business quoted and written within company guidelines

• Oversee all aspects of building operations, which include a five-hundred-room hotel, six hundred thousand square foot office building, thirty thousand square foot of retail, and a loading dock
• Manage and monitor daily performance of 13 associates
• Perform activity valuation analysis and prepare monthly activity reports with narrative summaries to property and facility management
• Meet all contractual scheduled hours with a minimum of unbilled overtime
• Coordinate and/or conduct sites-specific OJT, client-specific training, and quarterly refresher training for security personnel, as well as meet the company’s corporate training standards
• Oversee log entry system and administer the development of more effective programs
• Participate as member of the Company OSHA’s Safety Committee
• Maintain exemplary productivity, quality, and attendance standards