Quality Project Manager

🔥 13 hours ago

🌐 Argentina, Brazil, +1 more countries – Remote

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⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 10%

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Logo of IQVIA

IQVIA

10,000+ employees

💼 Consulting

🏭 Manufacturing

📣 Marketing

💰 $1G Post-IPO Debt on 2023-05

Consulting • Manufacturing • Marketing

IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.

📋 Description

• Serve as the liaison between Records Management and user departments regarding Trial Master Files • Apply clinical research records management expertise to provide project-related assistance across multiple projects, sites, and project teams • Ensure work complies with SOPs, policies, Good Clinical Practice (GCP), applicable regulatory requirements, and quality and timeline metrics • Ensure project timelines are met and facilitate transfer, imaging, scanning, retention, and disposition of records • Coordinate retrieval of requested records and prepare closed studies for transfer to final destinations • Monitor filing accuracy and compliance with IQVIA or customer file plans and SOPs • Conduct and manage imaging and scanning processes and train staff on applicable procedures • Maintain records center security and protect record integrity through SOP compliance • Interface with internal departments to support retrieval projects and meet information needs • Train team members on records management tasks, policies, and procedures • Serve as primary point of contact for internal and external clients • Coordinate transfer, recall, and disposition of records to commercial records storage centers • Oversee disposal of obsolete records and maintenance of records storage space, supplies, and equipment • Assist management with strategic goals, plans, cost proposals, and resource projections for records management projects • May function as team leader for records management projects

🎯 Requirements

• Bachelor’s degree in Records Management or a related field, or equivalent combination of education, training, and experience • Minimum of four (4) years of experience working in a technically related records management environment • Prior experience with Trial Master File (TMF) oversight, review and/or reconciliation across clinical studies • Strong knowledge of applicable research and regulatory requirements, including International Council for Harmonization (ICH), Good Clinical Practice (GCP), and relevant local laws, regulations, and guidelines • Working knowledge of technology applications relevant to records management environments • Ability to identify and analyze problems, develop effective solutions, and make sound decisions • Demonstrated ability to manage multiple tasks and projects within defined timelines while balancing competing priorities • Strong attention to detail and ability to remain focused under pressure • Excellent organizational, planning, and decision-making skills • Strong written and verbal communication skills, including a solid command of the English language • Ability to establish and maintain effective working relationships with internal and external clients • Demonstrated ability to lead and guide others

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