GCP Archivist at IQVIA

Parsippany, New Jersey, United States

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalIndustries

Requirements

Bachelor’s degree or equivalent and relevant industry experience
Minimum of 3/4 years working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organizations) with specific experience in clinical documentation and/or records & information management
Strong influencing and presentation skills
Ability to communicate effectively at all levels
High organizational awareness, including experience working in multi-disciplinary teams, across cultures and geographies
Good negotiation, problem solving and conflict resolution skills; experience establishing trusted relationships with internal and external stakeholders

Responsibilities

Act as Archivist, responsible for the management of archived records across multiple platforms
Collaborate closely with business and technical stakeholders to ensure records are maintained in compliance with regulatory standards and internal policies
Act as Archivist for physical records collections managed in local onsite CDGM archives and offsite storage
Ensure the archiving service for paper and electronic records is delivered in compliance with appropriate regulations and Sponsor’s policies, and per agreed SLAs to meet business needs
Act as Archiving subject matter experts supporting CDGM, business driven projects and activities relating to archive systems, processes and archived records
Provides audit/inspection readiness support in relation to archiving, contributes to root cause analysis, identification and creation/delivery of CAPAs
Serves as Subject Matter Expert on archiving training materials, formal and informal processes and tracking tools for electronic and physical clinical records
Executes vendor oversight plans, in relation to archive staff and other third parties, monitors service metrics and identifies opportunities for improvement to the operating model
Acts as point of escalation for issues
Identify and implement improvements to archive operations and services
May act as business lead for innovation projects to enhance archive services

Skills

Archiving

Clinical Trial Records

Regulatory Compliance

CDGM

Process Improvement

Audit Readiness

Training

Vendor Oversight

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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