Global Clinical Control & Outsourcing Project Lead II

RTP, NC, United States
Nov 25, 2020
Bio NC
Required Education
Masters Degree/MBA
Position Type
Full time
Global Clinical Control & Outsourcing Project Lead 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 contracts, SOWs, invoices, and other financial correspondence.
• Establishes internal relationships across functional areas (includes Legal, Compliance, Purchasing, Accounting, Treasury and Finance Dept, et al) in order to efficiently and accurately manage contract development related to clinical operations activities.
• Provide or review the month-end estimates by the vendors to be submitted for Accrual.
• Approves invoices for proper charging per the contract.
• Participates in writing/updating SOP's/ WP's as requested.

Additional Responsibilities:

Analyze vendor proposals for job bids where complex algorithms for pricing work components, need to be fully understood prior to implementation, for potential issues and financial impact. Writes RFPs in consults with clinical staff. Estimate cost for new clinical programs. Clarifies/consults with negotiators regarding contractual issues. Ensures all projects are reviewed on periodic basis and summarization of financial condition of project is communicated to study leaders. Act as primary business partner by providing guidance to study leaders and manager regarding potential change in scope of work requiring budget revision. Ability to manage and provide guidance to the Clinical Control Analyst as needed.

Strong knowledge of contracting, project/study financial analysis, and proposal preparation including principles, terminology and methodology. Ability knowledge of the Clinical Development process including knowledge of ICH GCP, FDA GCP, and GMP guidelines. Strong knowledge of general accounting, profit planning, standard and direct cost accounting, budgeting, financial analysis, new product financial feasibility, and utilization of data processing. Strong knowledge of continuous improvement methodologies. Strong knowledge of MS Excel. Strong organizational, interpersonal, process-orientation, oral and written communication skills. Analytical, mathematical, problem-solving, and active learning skills. Ability to perform complex and unusual assignments in budgeting/finance with little supervision under time constraints. Effectively communicate with both end-client leadership plus assessment team leadership. Ability to establish and maintain effective working relationships with co-workers, supervisor, technical staff and clients. Ability to prioritize and coordinate multiple work requirements to meet deadlines. Ability to prioritize workload and follow tasks through to completion and pay close attention to detail.



Global Clinical Control & Outsourcing Project Lead II: Masters or Bachelor's degree in business or related field, plus Typically requires a minimum of 5-10 years of relevant experience in an outsourcing, vendor management and financial management support capacity. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 30lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Interacts with others, relates sensitive information to diverse groups.

EEO Minorities/Disabled/Women/Veterans