Clinical Vendor Oversight Director
Clinical Vendor Oversight Director
This position is responsible as the SME for the Cerevel Oversight Plan for Clinical trials/programs, including the development and oversight of Vendor Improvement Plans when applicable. In addition, this role is responsible for leading the relationship management with CROs and other service providers who contribute to a clinical trial. Provide guidance and vendor management expertise to the business in the interpretation of contract language and issue resolution. Will co-host Clinical External Service Provider (ESP) kick-off meetings and project team interactions. Will play an important role in ESP governance.
This role will work closely with Cerevel Clinical Operations project team, Procurement and Finance colleagues to ensure seamless vendor oversight. Reports to the Vice President, Clinical Operations and Quality Management.
- Business Owner for the Vendor Oversight Plan and the Vendor Improvement Plan templates; serves as the Cerevel SME to Functional Areas and Clinical Project Teams
- Drives continuous improvement implementation related to Clinical Vendor Management/Oversight, inclusive of new provider selection
- Lead the evaluation of Clinical Vendors who can support Cerevel execution of our clinical trials in a more efficient and effective way; this may include vendors who provide services that are novel and/or innovative
- Interfaces with Health Authorities as necessary to articulate Cerevel’s Oversight practices and procedures, with ICH GCP E6/R2 requirements top of mind
- Coordinates with the Quality Management Director to support a Clinical Quality by Design model for all clinical trials
- Line manage the Clinical Oversight Lead role; responsible for overseeing the quality of the eTMF, drives Inspection Readiness and acts as the Clinical Operations liaison to the Quality Management function
- Stakeholder for relevant policies and procedures related to Clinical Vendor oversight
- Responsible for providing effective training to employees and external contractors related to Vendor Management/Oversight best practices
- Responsible for supporting the vendor change order process in collaboration with project team leadership to ensure effective controls related to changes in vendor scope and pricing
- Drives the onboarding of new vendors and acclimates them to Cerevel expectations as outlined in the Vendor Oversight Plan
- Lead/contributes to Clinical Operations departmental goals, projects and initiatives
- Performs other duties as assigned
Professional Experience/ Qualifications
- Solid understanding of GCP and pharmaceutical regulation
- Knowledge of scientific and clinical concepts within global clinical programs
- Strong understanding of the R&D business; ability to partner with the business functions to enable high quality outcomes
- Strong project management, interpersonal, and communication skills
- Experience in managing contract service providers
- 5 years of managerial and supervisory experience
- Strong computer skills with Word, Excel, PowerPoint, and Outlook
- 6+ years in the pharmaceutical industry, with clinical trial experience
- Desire to work in a fast-pace, dynamic environment
- Excellent communication and presentation skills
- Team player; experienced at developing talent
- A high degree of autonomy; takes accountability for work
- Very organized and efficient; delivers high-quality work
Bachelor of Science in a life science major required; Advanced Degree preferred
An attractive compensation package commensurate with this management role will be provided.
Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
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