Independent Drug Monitoring Manager - Sponsor Dedicated at IQVIA

Reading, England, United Kingdom

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical ResearchIndustries

Requirements

Bachelor’s or University degree (or equivalent related experience) in appropriate scientific or business discipline
6 years of relevant experience in clinical trial operations in the pharmaceutical industry, CRO, or equivalent related experience

Responsibilities

Provide global coordination for unblinded drug management and facilitate Independent Drug Monitoring (IDM) process between IDM Team and Global Trial Team
Ensure IDMM deliverables progress according to agreed timelines and support trial milestones; provide status updates as required
Ensure inspection readiness through compliance with company SOPs, GCP, applicable regulations, and guidelines from start-up through close-out
Take ownership for assigned IDMM responsibilities
Adhere to Sponsor’s SOPs, WIs, policies, GCP, and local regulatory requirements
Comply with relevant and on-time training requirements
Lead study teams in management of IDMM related processes and operations, ensuring blind is maintained
Provide input for development of pharmacy-related materials, including forms and manuals
Support system set-up including IVRS and EDC
Ensure adherence to quality of IDMM process/SOPs, including documentation and blinded escalation of major/critical issues; follow up to closure
Act as main point of contact for resolution of ad-hoc questions associated with IDMM issues
Resolve and document urgent/critical unblinded and pharmacy-related issues; investigate trends
Monitor status and resolution of major/critical issues via Issue Logs and Visit Report review process
Provide blinded updates to Trial Team on pharmacy-related and compliance issues
Take initiative to suggest and implement solutions to site-level issues
Oversee Independent Drug Monitors (IDMs) to ensure investigational product activities are addressed at sites; act as primary point of contact for IDMs
Provide communications and necessary information to IDMs on study updates (e.g., protocol amendments, timeline changes)
Review IDM monitoring visit reports (initiation, periodic, close-out) and provide feedback as needed
Provide training and re-training to new IDMs and site pharmacy staff
Ensure IDM visits occur within window and track any out-of-window visits per process
Ensure IDM monitoring visit reports and issue logs are up to date
Ensure existence and accuracy of relevant IDMM process documentation, communication, and monitoring plans
Provide input in audits and/or CAPAs
Assist in database lock/interim analysis; clean unblinded data and review unblinded queries if applicable
Create trial-specific IDMM training materials and requirements
Establish and maintain excellent working relationships with internal and external stakeholders
Maintain unblinded TMF and perform document management activities for inspection readiness
Provide feedback, training, coaching, and guidance to junior colleagues as needed
Work proactively to increase global awareness of IDM processes; train and educate stakeholders
Contribute to IDMM process improvement and training as applicable

Skills

GCP

SOPs

IVRS

EDC

Drug Monitoring

Pharmacy Management

Issue Logs

Regulatory Compliance

Team Leadership

Clinical Trials

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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