The Development Business Operations Vendor Qualification Manager will report to the Director, Development Business Operations and is responsible for leading vendor qualifications in the clinical outsourcing of global Phase I-IV clinical trials, which may include clinical monitoring, data management, biostatistics, medical writing, Phase 1 CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors. The Vendor Qualification Manager may also assist with other vendor assessments in the Development Business Operations group (i.e., IT Security Assessments, Anti-Bribery and Anti-Corruption Due Diligence, etc.).
The Vendor Qualification Manager will manage the entire life cycle of vendor qualification, comprised of vendor pre-qualifications and vendor re-qualifications. Aspects of the vendor pre-qualification and vendor re-qualification processes include, but are not limited to: assembling and leading cross-functional vendor qualification teams, tracking requests, vendor services risk assessments, scheduling, maintaining an approved vendor services list, maintaining libraries of standards & VQ Questionnaires, planning remote or onsite vendor qualifications, notifying vendors, setting agendas, conducting vendor qualifications, leading evaluations, closing vendor qualification reports, and routine report outs for senior management.
The Vendor Qualification Manager will work with Vendor Outsourcing Managers, Vendor Selection Teams and internal customers in the vendor qualification process and may assist with the planning of vendor capabilities presentations during the vendor bid defense meetings.
The Vendor Qualification Manager has executive presence; excellent communication, project management & critical thinking skills; and, is comfortable interacting with internal and external teams, such as, R&D Quality & Compliance, clinical operations, finance, legal, business conduct, vendor relationship management, payments, and vendors. Completes tasks and projects under minimal supervision and has the ability to manage competing priorities effectively and proficiently.
Demonstrates a thorough knowledge of Good Clinical Practice “GCP”, Good Pharmacovigilance Practices “GVP”, Good Laboratory Practice “GLP”, Good Documentation Practice “GDP” and ICH E6 R2 compliance requirements. Demonstrates a thorough understanding of current global and regional trends in compliance. Candidate has 10+ years of relevant experience in the pharmaceutical or bio-pharmaceutical industry; and, has a BS or BA with 8+ years of relevant experience.
Established in 2004, MWIDM currently employs over 3,500 industry professionals supported by 38 national and international locations throughout the U.S., India and Canada. It’s an exciting time at MWIDM as we make significant investments in growing our Healthcare staffing division.
Why Work Here?MWIDM is a certified minority and women owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. With over a decade of experience, MWIDM provides Workforce Solutions to a broad range of business sectors including Systems Integration, Banking & Finance, Telecommunications, Life Sciences, Healthcare, Energy, Technology and Supply Chain. Established in 2004, MWIDM currently employs over 3,500 industry professionals supported by 38 national and international locations throughout the U.S., India and Canada. It’s an exciting time at MWIDM as we make significant investments in growing our Healthcare staffing division.
MWIDM Inc. is one of the leading Staffing company with 3800 active workforce across the US, we provide great benefits and best pay rates.
San Mateo, CA