Clinical Scientific Expert I
Job Details
Job ID: REQ-10087555
Date Posted: September 8, 2026
Location: India
Site: Hyderabad, Telangana, India
Business Unit: Development
Division: Development
Functional Area: Research & Development
Job Type: Full-time
Employment Type: Regular
Shift Work: No
Company: Novartis Healthcare Private Limited
Role Overview
The Clinical Scientific Expert I (CSE I) provides clinical and scientific support across all phases of clinical studies under the guidance of the Associate/Clinical Development Medical Director ((A)CD(M)D).
The role supports compliance with Novartis processes, ICH Good Clinical Practice (GCP), and applicable regulatory requirements. The CSE I applies clinical data review principles to identify scientifically relevant insights, assess data plausibility, identify trends and signals, and evaluate risks related to clinical trial endpoints and patient safety.
The position is a core member of the Integrated Clinical Trial Team (iCTT) and may contribute to program-level activities as assigned.
Major Accountabilities
Clinical Data Review and Insights
Perform high-quality clinical data review at the patient level.
Identify clinical data insights through patient-level review and trend analysis.
Support interim analysis, database lock, and post-lock activities.
Facilitate identification and resolution of clinical data issues.
Assess data for scientific plausibility, integrity, consistency, and completeness.
Focus on subject safety and eligibility during clinical data review.
Identify trends, signals, and potential risks associated with trial endpoints and patient safety.
Identify cases requiring medical review.
Collaborate with relevant line functions to improve clinical data review and insight generation.
Support data analysis and remediation activities.
Data Review and Quality Strategy
Contribute to development of the Data Review Plan (DRP) and/or Data Quality Plan (DQP).
Support development and implementation of the study-level data review strategy.
Ensure protocol requirements are consistently implemented across the study.
Review protocol deviations and eligibility criteria.
Assess implementation of study assessments and other protocol requirements.
Support identification and resolution of data quality issues.
Case Report Forms and Data Capture
Contribute to Case Report Form (CRF) development in collaboration with relevant line functions.
Support implementation of data capture tools.
Ensure clinical data collection requirements are appropriately reflected in data capture processes.
Contribute to improvements in data collection and review processes.
Clinical Data Review Process Improvement
Identify opportunities to improve clinical data review processes.
Identify delinquent or redundant reports and data.
Support implementation of innovative data analysis processes and tools.
Contribute to efficient data review methodologies.
Support continuous improvement initiatives related to data quality, analysis, and clinical insights.
Clinical Documentation and Regulatory Support
Contribute to study-level clinical documents in collaboration with relevant line functions.
Support preparation of clinical sections of regulatory documents, including:
Investigator’s Brochures
Briefing books
Safety updates
Regulatory submission dossiers
Review and/or write clinical trial documentation for Clinical Study Report (CSR) activities.
Contribute to scientific publications and related clinical documentation.
Ensure clinical documentation is scientifically accurate and aligned with study data.
Pharmacovigilance and Patient Safety
Support pharmacovigilance activities when required.
Review and/or contribute to aggregate safety reports.
Support preparation and review of patient narratives.
Participate in Safety Monitoring Meetings (SMTs), where required.
Contribute to patient safety activities and identification of clinically relevant signals.
Escalate safety-related findings appropriately.
Training and Study-Level Meetings
Develop training materials for clinical trial teams.
Provide training to Integrated Clinical Trial Teams (iCTT).
Support and present at study-level meetings.
Participate in Investigator Meetings.
Support Data Monitoring Committee (DMC) meetings.
Participate in other relevant study meetings and scientific discussions.
Subject Matter Expertise
Develop subject matter expertise within assigned areas.
Build disease-area knowledge.
Develop expertise in clinical data review tools and processes.
Apply scientific and clinical knowledge to support study execution and data interpretation.
Maintain awareness of relevant scientific developments and clinical research practices.
Line Function and Organizational Contributions
Contribute to local and global line-function initiatives.
Support education and training initiatives.
Participate in process development and improvement projects.
Contribute to cross-functional clinical development initiatives.
Support program-level activities when assigned.
Essential Qualifications
Advanced degree in Life Sciences, Healthcare, or another clinically relevant discipline.
Preferred qualifications include:
Master’s degree
PharmD
MPharm
PhD
MBBS
BDS
MD
Required Experience
1–2 years of scientific, strategic, and operational experience in planning, executing, reporting, and publishing clinical studies in industry or academia.
OR
3–4 years of experience in Clinical Operations or a Clinical Scientific role.
Intermediate knowledge of planning, executing, reporting, and publishing global clinical studies.
Experience within a pharmaceutical company, Contract Research Organization (CRO), or academic research institution.
Clinical Research Knowledge
Good understanding of Good Clinical Practice (GCP).
Knowledge of drug development processes.
Understanding of clinical study planning and execution.
Knowledge of clinical data collection and reporting principles.
Understanding of clinical trial documentation and reporting requirements.
Familiarity with global clinical study processes.
Therapeutic and Scientific Knowledge
Strong scientific knowledge in at least one therapeutic area.
Understanding of basic disease mechanisms.
Knowledge of disease symptoms and clinical manifestations.
Understanding of standard of care and available treatments.
Knowledge of scientific endpoints and clinical outcomes.
Ability to apply scientific knowledge when reviewing clinical trial data.
Clinical Data and Technology Skills
Understanding of clinical data collection and reporting.
Ability to use clinical data systems and analytical tools.
Experience with Electronic Data Capture (EDC) systems.
Strong Microsoft Excel skills for data analysis and reporting.
Experience with Rave and/or OC-RDC is advantageous.
Ability to identify trends and patterns within clinical data.
Ability to assess data quality and identify potential risks.
Familiarity with statistical analysis methodologies.
Analytical and Scientific Writing Skills
Strong analytical and computational skills.
Ability to identify clinically relevant data trends.
Ability to interpret clinical data and identify potential signals.
Ability to determine when issues require escalation.
Knowledge and application of statistical analysis methodologies.
Strong medical and scientific writing skills.
Ability to communicate complex scientific information clearly and accurately.
Collaboration and Communication
Ability to collaborate effectively across organizational boundaries.
Strong cross-functional teamwork skills.
Ability to work with multidisciplinary clinical development teams.
Ability to resolve issues collaboratively.
Ability to recognize situations requiring escalation.
Strong communication and presentation skills.
Ability to contribute effectively to scientific and operational discussions.
Key Functional Areas
Clinical data review
Clinical data insights
Clinical research
Clinical study execution
Clinical trial data analysis
Data quality management
Patient safety
Pharmacovigilance support
Clinical documentation
Regulatory documentation
Clinical Study Reports
Scientific writing
Clinical trial systems
Data review strategy
Clinical trial process improvement
Therapeutic area expertise
Cross-functional collaboration
Key Systems and Tools
Electronic Data Capture (EDC) systems
Rave
OC-RDC
Microsoft Excel
Clinical data review tools
Clinical data analysis tools
Statistical analysis methodologies
Core Competencies
Clinical data review
Scientific analysis
Clinical research
Data interpretation
Patient safety
Risk identification
Trend and signal detection
GCP compliance
Drug development knowledge
Scientific and medical writing
Statistical analysis
Problem solving
Cross-functional collaboration
Communication and presentation
Data quality management
Clinical documentation
Uttar Pradesh :
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Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Bangor | Brewer |New Jersey :
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Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
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Bloomington | West Lafayette |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Idaho :
Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
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Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Hamburg |Rhineland Palatinate :
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Mitte |Mecklenburg Vorpommern :
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Saarbrucken |Switzerland :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | Australia | Richmond Hill | North York | Renfrew | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
Yavne | Kfar Saba | Be'Er Sheva | Tel Aviv | Netanya |Remote :
Remote - South America (Latin Americal) | Switzerland | Bountiful | Victoria | Castlebar | Milwaukee | Thailand | Lousiana | Faridabad | Melbourne | Tulsa | Green Way | Riga | Hungary | Remote - Middle East | Lenexa | Manipal | Minnesota | Medan | Perth | Bishop | Regulatory Labeling Manager (NA and LATAM Only) | Texas | Blue Bell | Ireland | Slovakia | French | Belgium | McFarland | Nairobi | Springville | Hammond | Xzagreb | Remote - Europe | Leinster | Zaragoza | Remote - Africa |Republic of Colombia :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Riyadh | Khulais | Jeddah | King Abdullah Economic City | Rabigh | Najran |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
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