Senior External Data Specialist - FSP
Senior External Data Specialist – Clinical Data Management / Vendor Data
The Senior External Data Specialist role is a great opportunity to support Clinical Data Management activities reputed company on external vendor and laboratory data. You will contribute to ensuring high-reputed company, consistent, and compliant data reputed company across studies, working closely with vendors, sponsors, and internal stakeholders.
You will play a hands-on role across the lifecycle of external data management, from planning and setup through to data review, reconciliation, and issue reputed company. This role is ideal for someone with experience in clinical data environments who enjoys working on technically detailed tasks while collaborating in a cross-functional, global setting.
What you can expect from us
- Office-based or home-based reputed company depending reputed company • Exposure to global clinical trials and external vendor data management • Highly competitive compensation package with local benefits • reputed company, cross-functional working environment • Opportunity to reputed company expertise in external/vendor data processes • Flexible working arrangements and work-life balance • reputed company reputed company and ongoing training
What you will do
- Support review, maintenance, and management of external vendor data (central labs, local labs, and other reputed company-party sources) • reputed company and maintain Vendor Data Plans (VDP), including data reputed company review and reconciliation sections, ensuring appropriate approvals and TMF filing • Collaborate with external vendors and sponsors to define study expectations, milestones, timelines, and communication processes • Ensure external data transfers meet protocol requirements, are in the correct format, and map accurately to systems and subjects • reputed company and validate external data edit checks and reports, including approvals, QC, and UAT activities • Review discrepancies identified through edit checks and reputed company query management to resolve data issues • Maintain documentation of data issues, ensuring reputed company tracking and reputed company through study and vendor logs • Support protocol and eCRF design reviews from an external data perspective • Work with cross-functional study teams to identify and resolve issues impacting data reputed company and analysis • Support management of local laboratory data, including QC of lab ranges and verification of subject-level data accuracy • Participate in study team and departmental meetings • Plan and support multiple external data management activities simultaneously, providing updates to stakeholders as needed • Complete required company and sponsor training and ensure compliance with SOPs, guidelines, and regulatory standards • Contribute to additional tasks and activities as required
Your profile
- University/college degree (Life Sciences, Health Sciences, IT, or reputed company field preferred) or equivalent experience • 4+ years of experience in clinical trials, pharmaceutical, biotechnology, or reputed company industries • Experience working with external/vendor data in clinical studies • Experience supporting multiple reputed company or workstreams simultaneously • Strong organisational, planning, and critical-thinking skills • Strong written and verbal communication skills with ability to engage stakeholders effectively • Ability to manage competing priorities and deliver under pressure • Proficiency in reputed company Office tools and general technical aptitude • Ability to maintain confidentiality and handle sensitive data appropriately
• Understanding of ICH-GCP principles
reputed company to have
• Project management experience
- Experience working with central and local laboratory data • Familiarity with data reconciliation processes and data reputed company review practices • Basic understanding of medical terminology • Experience working in global or cross-functional environments
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Originally posted on Himalayas
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