Clinical Vendor Relationship Manager (Clinical Systems) 8/30/2016
Partners with our internal customers, providing subject matter expert support based on a deep understanding of current Global Good Practices (e.g.GxP: GCP, GcLP, and cGMP) and related processes for the specific services provided by vendors to the clinical research industry including, requirements and regulatory expectations with the ultimate goal of issue escalation/risk mitigation, improved quality and increased performance from vendors. Serves as the global primary point of contact for the Company project teams for discussions regarding areas of expertise. GxP vendors include any vendors governed by GCP, GcLP, or cGMP guidelines including but not limited to Central/Specialty Laboratories, Contract Manufacturing Organization (CMOs), Depots, Contract Research Organizations (CROs), eSystems (CTMS, eDC, IxRS, ePRO, eTMF, LMS, etc.), Imaging/Core Laboratories and Central Readers, and Translators.
* Advises Vendor Management leadership to ensure the meeting of industry standards and expectations, and adherence to GxP and other applicable regulations including criteria for selection of vendors and responsibilities of various departments for implementing and overseeing vendors used on projects. Maintains awareness of industry best practices for relevant scopes of service including legal, ethical, and regulatory aspects.
* Instructs Company staff regarding the selection of vendors by project. Acts as the internal advocate for selecting preferred providers. Drives training internally within the organization so the Company staff understands the relationship and the working practices between the vendor and the Company.
* Provides study specific consultation and support with regards to vendor performance metrics and expectations including quality issue identification. Serves as an escalation point for study teams. Participates in the development and presentation of tools and templates. Conducts lesson learned.
* Facilitates effective vendor management by ensuring study teams establish performance metrics and clear expectations with vendors and monitor the vendor s compliance with established metrics/expectations throughout the life of the study.
* Reviews and authorizes Quality and/or Technical Agreements between the Company and the vendor as required. Contributes in the design for RFI (Request for Information) used to gather vendor specific information.
* Chairs quarterly meetings of global internal stakeholders to identify emerging needs and solicit feedback from the forum participants.
* Oversees vendor compliance. Collects, collates, and assesses data to monitor performance of GxP vendors utilized by the Company based on relevant input from all responsible departments. Communicates vendor compliance and performance to relevant stakeholders and provides input to corrective and preventive action associated with quality issue resolution. Escalates issues and communicates status to all appropriate parties.
* Maintains regular communication with vendors to ensure continued alignment and foster mutually beneficial relationships.
* Identifies more strategic use of vendors, improved efficiencies and cost savings. Interprets current and emerging industry trends and identify scientific benefits to our Sponsor studies. Ensures alignment with broader corporate goals and objectives.
* Line management responsibilities for staff members. For direct and indirect reorts, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring.
* Supports the analysis and selection of current and proposed preferred provider relationships in order to have the best in class vendors to support the Company. Identifies need to qualify new and existing vendors and communicate the need to the Vendor Qualification Group.
* Responds to RFI and other queries from Sponsors where subject matter expertise applies.
* Maintains and improves the vendor management database and associated internal webpage(s).
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
Maintains subject matter expertise through training (internal and external), reviews and/or preparation and presentation of papers, review of guidelines and regulations, etc.
BA/BS degree in a scientific discipline or health care field or equivalent combined education and experience. Moderate experience in related global clinical vendor service area and project management. Strong and comprehensive knowledge of GCP, cGMP, and/or GcLP regulations and guidelines. Experience with managing and supervising multiple project schedules and deliverables. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills. Ability to perform several tasks simultaneously in a dynamic environment in order to meet deadlines is essential.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.