Clinical Vendor Relationship Specialist (United States)
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POST DATE 9/14/2016
END DATE 11/9/2016
JOB DESCRIPTIONAPPLY Assists our internal customers, by providing support based on an 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 a point of contact for the Company project teams for discussions relating to GxP Vendors. 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.
Supports and assists the strategic growth of Clinical Vendor relationships. Implements outreach activities in order to positively impact and promote the use of the Company s Preferred Clinical Vendors. Represents CVM at Hand-off, Kick-Off, Strategic Vendor Meetings and Quickstart meetings to effectively assist with the selection and recommendation of Preferred Clinical Vendors to support clinical trial services.
* Supports the Company s Clinical Vendor Relationship Program by educating Project Managers on Company s Preferred Clinical Vendors and acts as an advocate for the selection of Preferred Clinical Vendors by project. Supports training within the organization so the Company staff understand the relationship and the working practices between the vendor and the Company.
* Monitors, measures, and reports on the compliance rate and effectiveness of the Company s use of Preferred Clinical Vendors to senior and executive management. Provides 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 .
* 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.
* Represents CVM at all relevant Project Initiation meetings to promote the use of Company s Clinical Preferred/Qualified Vendors. Serves as a point of contact to support Study Teams in selecting vendors who have the necessary proficiencies to perform clinical vendor services in a clinical study.
* 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 actions associated with quality issue resolution. Escalates issues and communicates status to all appropriate parties.
* Supports the analysis of current and proposed Preferred Vendor relationships in order to identify the best in class vendors to support the Company.
* Participates in the maintenance (and improvements to) the vendor management database and associated internal webpage(s)
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%). Develops subject matter expertise through training (internal and external), reviews and/or preparation and presentation of papers, review of guidelines and regulations, etc.
Minimum of five (5) years of global clinical vendor services and three (3) years of project management experience
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. Good knowledge of GCP, cGMP, and/or GcLP regulations and guidelines. Experience in working with 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.