Clinical Trial Associate

ACL Digital; Foster City (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

ACL Digital is seeking a Vendor Qualification Associate I who will report to the Director of Vendor Outsourcing. This role ensures high quality data and services across vendors supporting the global R&D portfolio, including Ph I-IV clinical trials.

You will lead or support vendor capability assessments, sourcing, contracting, and procurement, and coordinate with R&D Quality & Compliance, clinical operations, and finance.

Qualifications

• BS or BA with 5 years of relevant experience.
• PMP certification or equivalent.
• Deep understanding of vendor capability assessments, sourcing, contracting, procurement.
• Knowledge of clinical trial activities: monitoring, data management, biostatistics, medical writing.
• Ability to lead and/or support cross-functional efforts across R&D quality, compliance, finance, and vendors.

Responsibilities

• Conduct RFIs, Data Privacy and Security IT Assessments, and due diligence.
• Perform Financial Health Assessments and Inspection Readiness activities.
• Analyze data and benchmark to provide data-informed insights for strategy and improvement.
• Prepare presentations and trainings for stakeholders.
• Collaborate with R&D Quality & Compliance, clinical operations, legal, and vendor management teams.

Skills

Project management

Executive presence

Communication skills

Critical thinking

Vendor relationship management

Education

Bachelor's degree

PMP certification

Job description

Vendor Qualification Associate I, who will report to the Director of Vendor Outsourcing. The candidate will be responsible for ensuring high quality of data and services across all vendors supporting 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, 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.

BS or BA with 5 years of relevant experience. PMP certification or equivalent certification

Experience

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 II 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.