Clinical Data Manager - homebased (FSP) at IQVIA

Reading, England, United Kingdom

IQVIA Logo
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

Clinical Data Review
Scientific Data Review
EDC
Query Management
Data Management Plans
Data Flows
ICH-GCP
Regulatory Compliance
SOPs

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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