External Data Services Manager

🔥 12 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Manage day-to-day clinical data science activities and support the team in delivering quality outcomes • Lead development of Data Transfer Specifications (DTS) documents for external data providers and research partners • Author DTS documents and respond to external provider and internal stakeholder queries • Track DTS status across data types and programs and ensure completion dates meet study timelines and deliverables • Ensure data structures are consistent and compliant with appropriate data templates • Support data reconciliation and resolve data structure inquiries • Liaise cross-functionally to facilitate creation of new test codes • Participate in the Clinical Study Team as an extended team member • Oversee and train users in DTS and supplemental documents • Contribute to improvements in external data processes • Ensure study teams adhere to CDISC standards for external data • Comply with regulatory requirements relating to clinical protocols, biomarkers, imaging, eCOA, blinding, and analysis expectations • Process change requests to update existing DTS • Improve DTS templates to support data harmonization and downstream analytics • Provide external data management oversight to vendors, including functional discussions, partnership processes and standards, portfolio status, communication, and escalation • Review and contribute to eCRF and EDC builds relating to external data requirements

🎯 Requirements

• Minimum 8+ years of experience in external data services • Expertise in biomarker data types and/or Imaging data for oncology and non-oncology studies is preferred • Experience working with multiple data types/formats • Experience in managing clinical, biomarker data, eCOA and imaging data • Demonstrates broad knowledge of all applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines and CDISC standards for data collections • Demonstrates advanced knowledge of Data Management processes and industry best practices • Advanced knowledge and experience with extracting data into SAS, CSV, and XML formats is required • Legal right to work in the country where the role is based

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways