Global Clinical Control & Outsourcing Project Lead II

table.MiTabla { max-width: 1020px;!important

For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.

 

 

LOCATION: RTP

 

Global Clinical Control & Outsourcing Project Lead I/II

Provides all outsourcing, vendor management and financial management support to the Global R&D Clinical Dept.  Coordinates requests for proposals from service providers and supports the development and execution of all contracts with external providers related to the execution of the company’s clinical trials. Interfaces with vendors on all contract and finance related topics. Assists Operations with identifying issues and proposing solutions for items impacting the financial success of a projects/program and works closely with clinical development managers and directors to understand the needs of clinical programs in all therapeutic areas of development, and then creates partnerships with external providers to enable high quality and cost-effective services to meet established timelines for clinical trials.  Assist in the management of the development of the department's annual budget and forecasts.   Works with internal and cross-functional teams that includes Legal, Compliance, Purchasing, Accounting, Treasury and Finance Dept.             

 

Primary responsibilities for role:                                  

• Prepares, justifies, negotiates, and manages contracts and budgets of contract resource organizations, independent contractors, central laboratories, individual investigators, and any other parties related to the execution of clinical trials.                                   
• Identifies, screens, and selects CROs (prepares request for proposals) and central laboratories used in Grifols Inc clinical trials worldwide. Creates and maintains alliances with external providers of services.        
• Develops, refines, and adheres to standard operating procedures for the preparation, negotiation, and approval of grant and CRO budgets and contracts.                          
• Prepares scope of work, site and trial budgets, master study agreements, confidential disclosure agreements, and other contractual documents in consultation with the Legal Department.                          
• Reviews and understands key financial sources of information relative to contracts management, including the RFP, Work Orders, SOW, individual investigators contracts, and any other parties related to the execution of clinical trials.                                   
• Analyzes and conducts QA/QC on proposed SOW from contract resource organization to develop responsive business concerns. 
• Works with CRO and consultants to obtain business budgeting information, and ensure MSA, SOW, and WO are prepared according to Clinical Development SOP and in accordance with Institute policies.          
• Works with Study Manager and proposal leader in the development of proposal schedule.                    
• Responsible for the vendor evaluation process with study teams to include drafting a comprehensive report justifying the vendors selected and the associated costs, which is presented to Executive Management for consideration to proceed with the vendor award.                         
• Attends Study Team Meetings.  Coordinates, leads and follows-up on contractual concerns and issues assignments as appropriate. 
• Develop investigator site budget estimates per specifications according to available protocol information and fair market value costs.                              
• Assists with communication about and/or attends monthly projects review and kick off meetings.          
• Reviews/revises project forecast of costs with study managers and reports financial concerns to R&D Finance.                          
• Initiates and leads routine project management reviews with internal customers (including clinical development study managers/program directs, finance, and others as appropriate) to provide project leads with budget updates and variance analysis and develop consensus on monthly forecasts through review of trial activity and corresponding expenses.                                
• Prepares periodic progress reports, including project forecasts and resource projections.                      
• Prepares and organizes the annual external clinical budgets, key milestone updates, and periodic forecasts.                             
• Maintains an organized financial history of all clinical trials, including but not limited to, original contr