Clinical Sciences Trial Leader — Structured Job Summary
Company: Novartis
Novartis Official Website
Location: Hyderabad (Office)
Employment Type: Full-time
Requisition ID: REQ-10075370
Application Deadline: May 22, 2026
1. Role Overview
The Clinical Sciences Trial Leader contributes to and may lead global clinical trials, ensuring successful execution across schedule, quality, compliance, budget, and performance standards.
The role is a core member of the Clinical Trial Team (CTT) and plays a key part in clinical development operations, scientific oversight, and cross-functional trial execution.
2. Core Responsibilities
A. Clinical Trial Strategy & Protocol Development
Lead or support development of clinical protocols and amendments
Collaborate with Medical Leads and cross-functional teams on study design
Contribute to scientific input for study concepts, feasibility, and execution planning
Support regulatory study documentation (clinical sections of submissions)
B. Trial Execution & Operational Planning
Develop and implement study-level operational execution plans
Ensure trials are delivered on time, within scope, budget, and quality standards
Manage multiple global clinical trials concurrently
Coordinate cross-functional Clinical Trial Teams (CTTs)
C. Site Selection & Recruitment
Collaborate with stakeholders to identify and select high-performing clinical sites
Ensure patient recruitment commitments are met
Support enrollment strategy and execution
D. Data Review & Scientific Oversight
Lead or support ongoing scientific review of clinical trial data
Participate in:
Data interpretation
Safety trend analysis
Signal detection
Early results generation
Contribute to Clinical Study Reports (CSRs) and publications
Support dose escalation meetings and Phase I/II reviews
E. Risk, Budget & Vendor Management
Manage trial-level risks and mitigation strategies
Oversee study budgets and financial forecasting
Collaborate on vendor selection and operational timelines
Ensure efficient spend management and variance control
F. Governance, Leadership & Continuous Improvement
Promote best practices in trial management and operational excellence
Share lessons learned across teams and initiatives
Contribute to process improvement initiatives
Support mentoring, onboarding, and development of junior staff
3. Required Qualifications
Education
Bachelor’s degree in life sciences or healthcare required
Preferred: Advanced degree (PhD / MD / PharmD / Master’s)
Experience
~5+ years in clinical trials or clinical development
Strong experience in early clinical development preferred
Hands-on exposure to global clinical trial operations
Proven ability to manage multiple studies simultaneously
Core Knowledge Areas
ICH-GCP and global regulatory guidelines
Clinical trial methodology
Study execution and operational planning
Clinical finance and budget management
4. Core Skills
Clinical & Technical Skills
Clinical trial management
Clinical monitoring and data review
Clinical study report (CSR) development
Data management and auditing
Vendor management and CTMS tools
Project & Operational Skills
Project planning and execution
Risk management
Timeline and budget control
Agile decision-making in complex environments
Behavioral Skills
Strong leadership and collaboration
Stakeholder management
Problem-solving under pressure
Ability to manage ambiguity and shifting priorities
Strong interpersonal and communication skills
5. Key Skill Areas (From JD Keywords)
Clinical Research & Clinical Trials
Clinical Study Reports (CSR)
Clinical Trial Management Systems (CTMS)
Vendor & Data Management
Project Planning (Waterfall model exposure)
Health Sciences & Life Sciences
6. Organizational Context
This role sits within global Clinical Development and is central to executing early-to-late phase clinical trials. It connects scientific leadership with operational execution, ensuring high-quality evidence generation for regulatory and commercial decision-making.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Delhi | India | New Delhi | PAN-India |Assam :
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Digha | Kolkata | Mukundapur |Goa :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Bavaria |Bavaria :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Basel | Zurich |Serbia :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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Tel Aviv | Yavne | Kfar Saba | Netanya | Be'Er Sheva |Remote :
McFarland | Hungary | Minnesota | Riga | French | Lenexa | Lousiana | Hammond | Medan | Faridabad | Slovakia | Bountiful | Xzagreb | Belgium | Leinster | Texas | Green Way | Remote - South America (Latin Americal) | Bishop | Thailand | Switzerland | Victoria | Springville | Blue Bell | Ireland | Manipal | Remote - Europe | Remote - Middle East | Castlebar | Zaragoza | Remote, USA | Nairobi | Remote - Africa | Remote | Regulatory Labeling Manager (NA and LATAM Only) | Melbourne | Tulsa |Republic of Colombia :
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