PHARMAFull-time
Clinical Data Team Lead - External Data Acquisition
BANGALORE (IN)REMOTEPOSTED: 8/25/2026
PHARMAFull-time
HIRING ORGANIZATIONTHERMO FISHER SCIENTIFICLife Sciences / Scientific Instruments / Biotechnology
ROLE DEFINITION & RESPONSIBILITIES
Core Responsibilities
Serve as lead data manager for one or more clinical studies or support the lead data manager.
Lead and execute non-CRF external data acquisition across study setup, conduct, and closeout for multiple clinical studies.
Review protocols and study materials to identify non-CRF data collection requirements and design external-data acquisition strategies.
Develop, negotiate, and maintain Data Transfer Agreements (DTA) and Data Transfer Specifications (DTS).
Manage end-to-end external data acquisition and ensure external data is accurate, complete, timely, validated, and audit-ready.
Produce and maintain CDM non-CRF deliverables including DTA/DTS, Vendor Project Design Specifications, mapping documents, and validation artifacts.
Ensure study materials are audit-ready and appropriately filed in the electronic Trial Master File (eTMF).
Lead vendor management for eCOA/ePRO and other external data providers, including setup calls, requirements finalization, configuration review, documentation review, and deliverable negotiation.
Plan and execute formal user acceptance testing (UAT) for applications, email notifications, and custom/compliance reports; create test scripts, capture defects, coordinate resolution, and prepare validation summary reports.
Coordinate with Data Standards teams to maintain standard templates and libraries in line with CBER and other regulatory updates.
Provide technical expertise on SDTM mappings, XML/JSON/CSV formats, SFTP/API transfer mechanisms, data transformation, and ingestion processes.
Troubleshoot data integration issues and drive resolution with internal teams and external vendors.
Act as liaison to Project Leads, clients, management, vendors, and cross-functional stakeholders.
Develop and maintain data management project documentation and independently review deliverables against CDM guidelines.
Develop and deliver study-specific training for data management staff and facilitate knowledge-sharing sessions.
Monitor study metrics, produce project status reports, communicate risks and mitigations, and drive issue escalation and resolution.
Support project forecasting, resource planning, bid preparation, bid defense, administrative/financial management, and contract modification activities where required.
Mentor junior staff and provide direction to study teams.
Technical & Domain Standards
Apply clinical trial protocols, clinical data management procedures, regulatory requirements, SOPs, and client expectations.
Maintain confidentiality and quality of clinical and proprietary data.
Support integration across Clinical Data Management, Biostatistics, Data Standards, Clinical Operations, and IT.
Leadership & Impact
Lead external data acquisition activities across multiple concurrent clinical studies.
Coordinate vendors and multidisciplinary stakeholders to deliver high-quality clinical data on schedule.
Identify upstream/downstream risks and dependencies and implement appropriate mitigations.
Maintain SOP-aligned templates, checklists, documentation, and governance processes.
Train, mentor, and direct study team members while promoting data-management best practices and capability development.
Work Environment
Full-time role with a standard Monday-Friday schedule.
Listed as fully remote, with office-environment conditions and occasional domestic/international travel or site visits.
REQUIRED VERIFIED SKILLS
Clinical Data Management
End-to-End Clinical Data Management
External Data Acquisition
Non-CRF Data
Data Transfer Agreements
DTA
Data Transfer Specifications
DTS
eCOA
ePRO
Clinical Trials
Clinical Data Repositories
SDTM Mapping
XML
JSON
CSV
SFTP
API
Data Integration
UAT
Data Validation
eTMF
Regulatory Compliance
SOPs
Vendor Management
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Thermo Fisher Scientific is a global leader in serving science, providing an extensive range of analytical instruments, laboratory equipment, reagents, consumables, software, and services. They partner with pharmaceutical and biotech companies, hospitals, clinical diagnostic labs, universities, research institutions, and government agencies. The company's mission is to enable its customers to make the world healthier, cleaner, and safer.
TEAM SIZE: 130,000+ employees
INDUSTRY: Life Sciences / Scientific Instruments / Biotechnology
RECOMMENDED TRAINING
1/5
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