ICONMA
Vendor Qualification Associate I
ICONMA, Foster City, California, United States, 94420
Vendor Qualification Associate I
Location:
Foster City, CA (Hybrid) / RemoteDuration:
12 months with possible 6 months extensionDescription:Client is looking for a Vendor Qualification Associate I, who will report to the Senior Manager of Vendor Outsourcing. The candidate will be responsible for ensuring high quality of data and services across all vendors supporting Client global R&D portfolio – Ph I-IV clinical trials.The candidate should have a deep understanding of vendor capability assessments, sourcing, contracting, procurement, category management, and inspection readiness activities as they will be leading and/or supporting those cross-functional efforts. The candidate should also have an understanding of various clinical trial activities such as clinical monitoring, data management, Real World Data/Evidence (RWD/RWE), biostatistics, medical writing, Ph 1 CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors.Daily activities will include, but are not limited to:Conducting Request for Information (RFI)Data Privacy and Security IT AssessmentsAnti-Bribery and Anti-Corruption Due DiligenceVendor Subcontractor Process ManagementFinancial Health AssessmentsInspection Readiness Preparation ActivitiesData Analyses and Benchmarking to Provide Data Informed Insights into Strategies and Continuous Improvement InitiativesPresentations and TrainingsThe candidate should have executive presence, excellent communication skills, project management & critical thinking skills; and is comfortable interacting with internal stakeholders and external vendors. The Vendor Qualification Associate I will be regularly partnering with team members such as R&D Quality & Compliance, clinical operations, finance, legal, business conduct, vendor relationship management, payments, and vendors.The Vendor Qualification Associate I is expected to complete 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.Minimum Requirements:Candidate has 5+ years of relevant experience in the pharmaceutical or biopharmaceutical industry; and, has a BS or BA. PMP certification or equivalent certification. Candidates can be current or former project managers with project management experience in Pharmaceutical or Healthcare industries.Intake Notes:Top 3 Required Skill Sets:R&D Clinical Procurement ExperienceDeep understanding of Quality and Compliance across Pharmaceutical or Healthcare industriesTop 3 Nice to Have Skill Sets:Vendor QualificationVendor OutsourcingVendor ContractingRequired Degree or Certification:BS or BA
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Location:
Foster City, CA (Hybrid) / RemoteDuration:
12 months with possible 6 months extensionDescription:Client is looking for a Vendor Qualification Associate I, who will report to the Senior Manager of Vendor Outsourcing. The candidate will be responsible for ensuring high quality of data and services across all vendors supporting Client global R&D portfolio – Ph I-IV clinical trials.The candidate should have a deep understanding of vendor capability assessments, sourcing, contracting, procurement, category management, and inspection readiness activities as they will be leading and/or supporting those cross-functional efforts. The candidate should also have an understanding of various clinical trial activities such as clinical monitoring, data management, Real World Data/Evidence (RWD/RWE), biostatistics, medical writing, Ph 1 CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors.Daily activities will include, but are not limited to:Conducting Request for Information (RFI)Data Privacy and Security IT AssessmentsAnti-Bribery and Anti-Corruption Due DiligenceVendor Subcontractor Process ManagementFinancial Health AssessmentsInspection Readiness Preparation ActivitiesData Analyses and Benchmarking to Provide Data Informed Insights into Strategies and Continuous Improvement InitiativesPresentations and TrainingsThe candidate should have executive presence, excellent communication skills, project management & critical thinking skills; and is comfortable interacting with internal stakeholders and external vendors. The Vendor Qualification Associate I will be regularly partnering with team members such as R&D Quality & Compliance, clinical operations, finance, legal, business conduct, vendor relationship management, payments, and vendors.The Vendor Qualification Associate I is expected to complete 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.Minimum Requirements:Candidate has 5+ years of relevant experience in the pharmaceutical or biopharmaceutical industry; and, has a BS or BA. PMP certification or equivalent certification. Candidates can be current or former project managers with project management experience in Pharmaceutical or Healthcare industries.Intake Notes:Top 3 Required Skill Sets:R&D Clinical Procurement ExperienceDeep understanding of Quality and Compliance across Pharmaceutical or Healthcare industriesTop 3 Nice to Have Skill Sets:Vendor QualificationVendor OutsourcingVendor ContractingRequired Degree or Certification:BS or BA
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