Clinical Data Team Lead
Company: Thermo Fisher Scientific
Work Schedule: Standard (Monday–Friday)
Work Environment: Office-Based
About the Role
Thermo Fisher Scientific is seeking a Clinical Data Team Lead to lead and manage clinical data management activities across multiple clinical studies.
In this role, you will act as the lead data manager or support senior leads while ensuring end-to-end execution of clinical data processes. You will also manage external (non-CRF) data acquisition, vendor integration, and data ingestion activities across the study lifecycle.
You will work closely with cross-functional teams and external vendors to ensure timely, accurate, and audit-ready clinical data delivery.
The organization has supported:
Top 50 pharmaceutical companies
750+ biotech companies
2,700+ clinical trials across 100+ countries
Key Responsibilities
1. Clinical Data Leadership & Study Oversight
Act as lead data manager for one or more clinical studies.
Guide team members on protocol application in daily tasks.
Serve as liaison between:
Project leads
Clients
Internal stakeholders
Communicate study progress, risks, and updates to management.
Monitor study metrics and ensure operational excellence.
2. External Data (Non-CRF) Management
Lead end-to-end external data acquisition across study lifecycle:
Study setup
Study conduct
Study closeout
Ensure accurate and timely ingestion of external data sources:
eCOA / ePRO
Devices
Laboratory systems
Registries
Third-party vendors
3. Data Integration & Standards
Develop and maintain:
Data Transfer Agreements (DTA)
Data Transfer Specifications (DTS)
Ensure automated and validated data ingestion into clinical repositories.
Collaborate with Data Standards teams to maintain templates and libraries.
Support regulatory alignment (e.g., CBER updates).
4. Vendor Management & UAT
Manage external vendors for eCOA/ePRO and other data sources.
Conduct setup calls and finalize system requirements.
Review vendor deliverables:
Screenshots
User guides (English)
System configurations
Plan and execute User Acceptance Testing (UAT):
Create test scripts
Identify and track defects
Lead resolution discussions
Prepare validation summary reports
5. Technical & Data Support
Provide expertise on data formats and integrations:
SDTM mappings
XML / JSON / CSV
Manage data transfer mechanisms:
SFTP
APIs
Troubleshoot data ingestion and integration issues.
Ensure data quality across systems and vendors.
6. Documentation & Compliance
Maintain CDM deliverables:
DTA / DTS documents
Vendor specifications
Mapping documents
Validation artifacts
Ensure all documentation is:
Audit-ready
Stored in eTMF
SOP-compliant
7. Training & Team Development
Mentor and train junior staff and FSP teams.
Conduct knowledge-sharing sessions.
Support capability building across teams.
8. Risk & Project Management
Identify risks and dependencies across processes.
Propose mitigation strategies.
Ensure alignment across:
CDM
Biostatistics
Data Standards
Clinical Operations
IT teams
Support project planning and resource forecasting.
Educational Qualifications
Bachelor’s degree or equivalent in a relevant field.
Experience Requirements
Minimum 6+ years of experience in:
End-to-end Clinical Data Management
External data acquisition
Clinical trial data integration
Vendor management
Required Skills & Competencies
Technical Skills
Strong understanding of:
Clinical data management systems
Data integration workflows
SDTM standards
Data formats (XML, JSON, CSV)
Experience with:
Data transfer processes (SFTP, API)
Vendor systems (eCOA/ePRO platforms)
Analytical Skills
Strong problem-solving and troubleshooting abilities.
Ability to manage complex multi-study environments.
Strong attention to detail and data accuracy.
Communication & Leadership Skills
Excellent written and verbal communication.
Strong stakeholder management and client-facing skills.
Ability to lead teams and influence across functions.
Ability to train, mentor, and guide teams.
Personal Attributes
Strong organizational and multitasking abilities.
Ability to work independently and collaboratively.
Flexibility and adaptability in dynamic environments.
Strong decision-making and risk management capability.
High level of confidentiality and professionalism.
Working Conditions
Office-based work environment.
Exposure to standard office equipment.
Occasional travel:
Domestic
International
Occasional site visits as required.
Why Join Thermo Fisher Scientific?
At Thermo Fisher Scientific, you will be part of a global organization committed to:
Scientific innovation
Advanced clinical research operations
Data-driven healthcare transformation
Collaboration across global teams
Professional growth and leadership development
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