Senior Clinical Data Manager at IQVIA

Durham, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

BS/BA degree or higher preferably in Health Sciences, or BS/BA degree or higher with professional clinical experience/exposure
5 years Data management experience
Leadership experience
Data Management experience preferably including clinical data review or significant experience with clinical data review
Knowledge in medical terminology (preferable)
Collaboration with Clinical teams
Experience in clinical drug development within the pharmaceutical industry or related industry
College graduate with Data management experience or clinical data review

Responsibilities

Perform scientific (complex) clinical data review in close collaboration with the Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS)
Provide scientific data review support for more than one low to moderate complexity trial or one high complexity trial
Tap into technical and clinical expertise, closely collaborating with SRP, SRS, Data Management functions, and the rest of the study team for data management related activities, focusing on complex indication and therapy related elements
Review all necessary data flows and Data Management Plans, and perform continuous (complex) data review activities on studies in the assigned program
Provide input into study specific and/or indication specific data collection tools from the protocol design stage onwards
Review (complex) scientific study data, manage CDM and SRS/SRP related queries in eDC system, and hold discussions with SRS/SRP
Participate in other review activities (e.g., Coding, SAE reconciliation)
Lead and/or attend meetings as appropriate
Take a leadership role with SRP/SRS and collaborate with the GDM to establish, align, and confirm scientific clinical data review expectations for assigned trial(s)
With the trial customer, CRO, and other functional partners, create the Integrated Review Plan ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency
Review related clinical data management documents
Ensure compliance with regulatory guidelines and documentation requirements
Ensure real-time inspection readiness of all assigned deliverables for the trial; participate in Regulatory Agency inspections and clients' internal audits as necessary
Plan and track applicable CDM deliverables
Ensure CDM deliverables are on time
Take a leadership role in collaborating with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are met
Adhere to applicable Clients SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc

Skills

Clinical Data Management

ICH-GCP

Data Review

eDC Systems

Data Management Plans

SAE Reconciliation

Coding

Protocol Design

Query Management

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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