Senior Clinical Data Team Lead (Senior DTL) - FSP at IQVIA

Reading, England, United Kingdom

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Clinical ResearchIndustries

Requirements

BS/BA in scientific discipline
At least 7 years related experience in a pharmaceutical/biologics/biotechnology company
Experience working in clinical drug development through Phase 3 in an outsourced CRO model; experience with drug development in rare genetic diseases preferred
Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems
Knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH
Experience working with Medidata Rave
Experience using standardized medical terminology, including MedDRA and WHODrug
Experience working with MS Office Suite (Excel, Word, PowerPoint) and familiarity with MS Project
Excellent written and oral communications skills
Highly motivated and flexible, with excellent organizational and time management skills
Ability to work independently and as part of a multi-disciplinary team
Understanding of ICH GCP as well as general knowledge of industry practices and standards
Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11
NDA/MAA experience

Responsibilities

Contribute to data management activities as a lead study data manager in support of Client's clinical studies
Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing
Monitor data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews
Oversight of database lock activities and ultimate archiving of study data
Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors
Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews
Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation
Contribute to development and implementation of department workflows and infrastructure strategy (such as preferred provider interactions, SOPs, and templates) that reflects data collection standards, consistent with industry best practice and regulation
Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors
Participate in the training of external vendors and site staff
Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met
Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc
Support GCP inspection readiness

Skills

Clinical Data Management

eCRF

Edit Checks

User Acceptance Testing

Database Build

Database Lock

Data Cleaning

Data Coding

CRF Completion Guidelines

Data Transfer Specifications

GCP

SOPs

CRO 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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