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Advanced Clinical · 3 hours ago

Quality Management Specialist II (2649-1)

Princeton, NJ

Contract

Onsite

Mid Level

Advanced Clinical is a company focused on providing quality oversight in clinical research. The Quality Management Specialist II will support ongoing studies, consult on quality issues, and participate in risk assessments and audits to ensure compliance and best practices.

BiotechnologyConsultingHealth CareInformation TechnologyPharmaceuticalStaffing Agency

Culture & Values

H1B Sponsor Likely

Responsibilities

CW shadows 3 ongoing studies and supports 7 ongoing studies (planning to reporting stage) to provide Quality oversight, to recommend best practices

Communicates and collaborates with the stakeholders (CM and FAs) partnering for cross-functional team support and attendance of project and study level meetings

With the assistance of Senior GCP Level 1 members, consults on major and critical quality issues, potential Serious Breaches, significant noncompliance, data integrity issues and protocol deviations, escalates to Senior Management, and performs periodic resolution checks for assigned studies

Supports risk assessments and risk-based approaches for the annual GQM Audit Plan, identifies the number of site audits and vendor audits based on risk-criteria with input from study teams

Provides study and site related information and documentation to the audit team, GCP Level 2 in preparation for audits

Participates in the risk assessment of preferred and active vendors utilizing risk assessment tools to prepare the annual GQM Vendor Audit Plan

Involved in CAPA review of Quality Issues, Audits, Inspections, eTMF audit responses

Participates and contributes to weekly, monthly, and quarterly GQM GCP meetings

Attends QA:QA and Quality Council meetings with CRO accompanied by a Senior Member from the GCP In-Line Quality (Level 1)

Participates in the review and harmonization process of controlled documents such as protocols/ICF, CSRs, amendments, procedural documents & templates

Receives GCP training of ICH Guidelines E6 R3 and Modules from 21CFR and reads GCP Material

Team Members in training participate in weekly team support meetings

Involved in the Portfolio-wide proactive Inspection Readiness support (Sponsor, Site, CRO) - conducts Do & Don’t training, participates in interview preparations/debriefs, assesses Inspection Readiness Visits and Pre-Inspection Visits outcomes

Reviews and assesses Pharmacovigilance System Master File (PSMF) and performs PV related activities as assigned

Qualification

GCP ICH E6 knowledgePharmaceutical backgroundRisk assessmentCAPA reviewCollaboration skills

Required

Bachelors Degree

Preferred

some Pharmaceutical background

GCP ICH E6 knowledge

Benefits

Health coverage

Life insurance

Disability insurance

401k benefits

Company

Advanced Clinical

Advanced Clinical is a pharmaceuticals company offering CRO, FSP, quality, and validation services.

Founded in 1994

Deerfield, Illinois, USA

501-1000 employees

http://advancedclinical.com

H1B Sponsorship

Advanced Clinical has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (8)

2024 (4)

2023 (1)

2022 (3)

2021 (5)

2020 (8)