Clinical Data Manager - homebased (FSP) at IQVIA

Reading, England, United Kingdom

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Oncology, Cardiovascular & MetabolismIndustries

Requirements

Minimum 4+ years of experience supporting studies within the Oncology or CV&M therapeutic area
Prior experience collaborating closely with SRPs, SRSs, and Data Management functions
Demonstrated experience in performing scientific (complex) clinical data review
Understanding of and adherence to applicable Client SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc
Experience reviewing data flows and Data Management Plans

Responsibilities

Perform continuous (complex) data review activities on assigned studies
Collaborate with SRPs/SRSs and the GDM to establish, align, and confirm scientific clinical data review expectations
Provide input into study-specific and/or indication-specific data collection tools from the protocol design stage onwards
Manage CDM and SRS/SRP related queries within the EDC system
Review related clinical data management documents
Create and review the Integrated Review Plan, ensuring quality, scientific content, organization, clarity, accuracy, format, and consistency
Lead and/or attend meetings as appropriate
Review content and integration requirements for eCRFs and other data collection tools
Establish conventions and quality expectations for clinical data

Skills

Key technologies and capabilities for this role

Clinical Data ReviewScientific Data ReviewEDCQuery ManagementData Management PlansData FlowsICH-GCPRegulatory ComplianceSOPs

Questions & Answers

Common questions about this position

Is this position remote or home-based?

Yes, this is a homebased position as indicated by the job title.

What is the salary for this role?

This information is not specified in the job description.

What experience is required for this position?

Minimum 4+ years of experience supporting studies within the Oncology or CV&M therapeutic area, prior experience collaborating with SRPs, SRSs, and Data Management functions, and demonstrated experience in performing scientific (complex) clinical data review are required.

What therapeutic areas are relevant for this role?

The role requires extensive experience within the Oncology or Cardiovascular & Metabolism (CV&M) therapeutic area.

What makes a strong candidate for this Clinical Data Manager role?

A strong candidate has 4+ years in Oncology or CV&M, experience in complex scientific clinical data review, collaboration with SRPs/SRSs/Data Management, understanding of regulatory compliance like ICH-GCP, and skills in reviewing data flows and Data Management Plans.

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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