Junior Project Manager/Coordinator - Clinical

Job Title: Vendor Qualification Associate I - Clinical PM

Location: Foster City, CA

Hybrid: 3 days a week minimum

Description

·      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’s 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 Assessments, Anti-Bribery and Anti-Corruption Due Diligence, Vendor Subcontractor Process Management, Financial Health Assessments, Inspection Readiness Preparation Activities, Data Analyses and Benchmarking to Provide Data Informed Insights into Strategies and Continuous Improvement Initiatives, Presentations, and Trainings.

·      The 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. Candidate has 5 years of relevant experience in the pharmaceutical or biopharmaceutical industry; and, has a BS or BA. (1) PMP certification or equivalent certification, (2) Candidates can be current or former project managers & (3) Project management experience in Pharmaceutical or Healthcare industries

Skills:

•      Strong interpersonal communication skills

•      Attention to detail and proactive management of quality findings will be integral to the team’s success

•      Strong project management, organization, and critical thinking skills

•      Comfortable interacting with internal stakeholders and external vendors

•      Executive presence

Required Years of Experience: 3-5 years

•      Top 3 Required Skill Sets: 1) R&D Clinical Procurement Experience (2) Candidates can be current or former project managers & (3) Deep understanding of Quality and Compliance across Pharmaceutical or Healthcare industries and Excel

Top 3 Nice to Have Skill Sets:

•      Vendor Outsourcing, Subcontractor Management, Vendor Contracting and System skills (Veeva, RDMS, TMF etc.)

•      Unique Selling Point of this role: Growth Mindset, Proactive Leader to drive initiatives, Strong written and Verbal Communication skills, Passionate, and Able to thrive in a dynamic work environment

•      No BS or BA is a Disqualifier