Clinical Outsourcing Specialist

Clinical Outsourcing Specialist will be a member of the clinical team with a primary focus on clinical outsourcing and vendor management including driving vendor selection process, managing the request for proposals, liaising with legal and sourcing on contracting and price negotiations, managing purchase orders, overseeing the new vendor process, contributing to outsourcing strategy and vendor oversight.

Essential Duties and Responsibilities

• Support Clinical Operation in the preselection process of external providers
• Manage proposals for clinical services including requesting, evaluating, and negotiating proposals until contract signature
• Coordinate the outsourcing process with internal and external functions including global sourcing, legal, compliance and finance
• Manage and lead evaluation meetings
• Set-up contracts and coordinate the contracting process
• Review and compare budgets for completeness of assumptions
• Create comparison sheets of the proposals
• Set-up purchase orders in Ariba
• Collaborate with Quality to drive vendor qualification activities
• Support the tender process in collaboration with respective functions
• Collect feedback about the collaboration with the external providers
• Manage oversight meetings with preferred provider(s)
• Monitor vendor performance
• Provide support in case of escalation with external provider(s)
• Develop performance indicators for external provider
• Manage the change order process with external providers in collaboration with the respective functions
• Coordinate contract amendments and reconciliation
• Provide training of clinical outsourcing processes
• Improve outsourcing processes and review and update relevant SOPs
• Ensure cross-functional collaboration
• Support updates of contract templates
• Attend meetings or conferences with respect to outsourcing topics

Knowledge, Skills and Abilities

• Knowledge in clinical research and the conduct of clinical trials - Required
• Knowledge in commercial and contractual aspects for multinational clinical trials - Required
• Strong negotiation skills - Required
• Fluent (business) English - Required
• Excellent meeting management and presentation skills - Required
• Excellent keyboard skills, with experience using Microsoft Office (Word, Excel, Power Point, Outlook) applications - Required

Experience

• 3 year(s): - Experience in clinical outsourcing management (>3 years)- Experience in sponsor//vendor contract negotiation and management- Experience in comparing supplier bids and internal benchmarking data- Experience with budget management of complete outsourced clinical trials

Education

• Bachelor of Business Administration or better

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)