Clinical Data Team Lead
Company: Thermo Fisher Scientific
Work Schedule: Standard (Monday–Friday)
Work Environment: Office-based
Location: Typically India / Global (varies by project assignments)
Expected Salary
₹8–18 LPA CTC (typically ₹10–15 LPA for professionals with 2–5 years of clinical data management experience)
Role Overview
The Clinical Data Team Lead is responsible for leading data management activities for clinical trials. The role involves overseeing study data operations, ensuring regulatory compliance, coordinating with clients, and guiding junior data management staff across multiple clinical studies.
Key Responsibilities
Clinical Data Management Leadership
Lead data management activities for one or more clinical studies.
Apply protocol requirements to daily data management tasks.
Ensure adherence to SOPs, regulatory guidelines, and client expectations.
Client & Stakeholder Management
Act as liaison between project teams, clients, and internal stakeholders.
Communicate study progress, risks, and updates to management and sponsors.
Study Planning & Execution
Develop and maintain clinical data management documentation.
Review data deliverables and ensure quality compliance.
Monitor study metrics and project status reports.
Team Training & Mentorship
Train study team members on protocol-specific data processes.
Mentor junior data management staff.
Support resource planning and workload allocation.
Project Support & Operations
Assist in forecasting project timelines and resource needs.
Identify out-of-scope activities and support contract modifications.
Participate in bid preparation and client presentations (when required).
Required Qualifications
Education
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related field.
Experience
Minimum 2+ years in Clinical Data Management or related clinical research operations.
Key Skills
Technical & Domain Skills
Clinical Data Management (CDM)
Understanding of clinical trial protocols
Knowledge of regulatory guidelines (GCP, FDA, EMA basics)
Tools & Systems
Clinical data management systems (e.g., EDC tools like Medidata, Oracle InForm)
Soft Skills
Strong communication and stakeholder management
Analytical and problem-solving ability
Attention to detail and data accuracy
Ability to manage timelines and priorities
Leadership and mentoring capability
Preferred Qualifications
Experience working in CROs or global clinical trials.
Exposure to multi-country or large-scale studies.
Experience handling client-facing responsibilities.
Strong documentation and reporting skills.
Ideal Candidate Profile
Clinical research professional with 2–5 years of CDM experience.
Strong understanding of clinical trial workflows.
Comfortable leading small teams and interacting with global clients.
Detail-oriented with strong regulatory compliance awareness.
Career Growth
Clinical Data Associate → Senior CDA → Clinical Data Team Lead → Clinical Data Manager → Associate Director → Director Clinical Data Management
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