Central Monitor
Company: ICON plc
Location: Bangalore, India (Remote)
Work Mode: Remote
Department: Clinical Operations / Central Monitoring
Employment Type: Full-Time
Experience: 6+ years of experience in Clinical Research, including at least 4 years in Central Monitoring, Study Management, Clinical Data Management, or Biostatistics, with expertise in risk-based monitoring and clinical data analytics.
Salary Package: ₹18–30 LPA (Approx., based on current market standards; final compensation depends on candidate experience, therapeutic area expertise, and leadership capabilities.)
Role Overview
The Central Monitor is responsible for ensuring data quality, patient safety, and study integrity throughout the clinical trial lifecycle using centralized monitoring and risk-based monitoring (RBM) methodologies. The role collaborates with global cross-functional teams to identify, assess, and mitigate clinical trial risks through advanced data analytics, central monitoring tools, and quality oversight.
Key Responsibilities
Central Monitoring & Risk Management
Conduct centralized monitoring activities across multiple clinical studies.
Facilitate risk assessments throughout the clinical trial lifecycle.
Identify, evaluate, and proactively manage study risks.
Develop and maintain Central Monitoring Plans (CMPs) in collaboration with study teams.
Support Risk-Based Monitoring (RBM) strategies across global clinical trials.
Clinical Trial Oversight
Support study start-up, conduct, and close-out activities.
Define and monitor:
Key Risk Indicators (KRIs)
Quality Tolerance Limits (QTLs)
Review and interpret KRI and QTL outputs across study sites, countries, and regions.
Identify trends, deviations, and potential quality issues requiring intervention.
Data Analytics & Quality Monitoring
Utilize clinical data analytics to monitor study performance and quality.
Analyze centralized monitoring outputs to identify emerging risks.
Ensure patient safety, protocol compliance, and data integrity.
Support implementation of corrective and preventive actions (CAPA) where required.
Cross-Functional Collaboration
Collaborate with:
Clinical Operations
Study Management
Clinical Data Management
Biostatistics
Programming teams
External vendors
Lead risk mitigation discussions with cross-functional stakeholders.
Serve as the primary point of contact for central monitoring systems and tools.
Vendor & Study Oversight
Oversee outsourced central monitoring activities.
Ensure vendor deliverables meet quality, compliance, and timeline expectations.
Participate in vendor selection, evaluation, and performance management.
Monitor study trends and communicate findings to study management teams.
Regulatory Compliance & Documentation
Ensure Trial Master File (TMF) documentation is complete, accurate, and inspection-ready.
Support regulatory inspections, sponsor audits, and internal quality audits.
Maintain compliance with:
ICH-GCP Guidelines
Regulatory requirements
Company SOPs
Risk-Based Monitoring principles
Contribute to continuous process improvement initiatives.
Educational Qualification
Bachelor's degree in:
Biological Sciences
Life Sciences
Statistics
Health Sciences
Computer Science
Or a related discipline
Preferred: Advanced degree (Master's or equivalent) and professional certification in Clinical Development or related field.
Required Experience
Minimum 6+ years of Clinical Research experience.
At least 4 years of experience in one or more of the following:
Central Monitoring
Study Management
Clinical Data Management
Biostatistics
Experience with Risk-Based Monitoring (RBM) methodologies.
Exposure to multiple therapeutic areas is highly preferred.
Experience supporting regulatory submissions and audits.
Experience in vendor oversight and cross-functional leadership.
Technical Skills
Strong knowledge of:
Risk-Based Monitoring (RBM)
Central Monitoring methodologies
Clinical trial operations
Clinical data analytics
Trial Master File (TMF) management
Experience with:
KRI and QTL monitoring
Clinical data systems
EDC platforms
Clinical analytics and reporting tools
Proficiency in Microsoft Office Suite, particularly Excel.
Understanding of ICH-GCP guidelines and global regulatory requirements.
Key Competencies
Strong analytical and critical thinking skills.
Excellent risk assessment and problem-solving abilities.
Effective leadership and decision-making skills.
Strong stakeholder and vendor management capabilities.
Excellent communication and presentation skills.
Ability to work independently in a global, cross-functional environment.
High attention to detail with a quality and compliance mindset.
Strong organizational, planning, and time management skills.
Continuous improvement and process optimization mindset.
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 | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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Goa | Panaji | Verna |Bihar :
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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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Birmingham |Virginia :
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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 :
Lebanon | Macon | Manchester |Portugal :
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 :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
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 :
Uxbridge | Australia | Richmond Hill | Mississauga | Renfrew | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |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 :
Almaty |Republic of Thailand :
Bangkok |Israel :
Kfar Saba | Yavne | Netanya | Be'Er Sheva | Tel Aviv |Remote :
Green Way | Riga | Regulatory Labeling Manager (NA and LATAM Only) | Victoria | Remote - South America (Latin Americal) | Blue Bell | Tulsa | Ireland | Minnesota | Castlebar | French | Zaragoza | Perth | Remote - Middle East | Hammond | Bountiful | Bishop | Lenexa | Remote - Europe | Slovakia | Texas | Leinster | Xzagreb | Nairobi | Springville | Faridabad | Hungary | Medan | Switzerland | Thailand | Remote - Africa | Lousiana | Manipal | Milwaukee | Belgium | McFarland | Melbourne |Republic of Colombia :
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Brentwood |Bucharest :
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Buenos Aires |Republic of Egypt :
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New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
King Abdullah Economic City | Jeddah | Najran | Riyadh | Khulais | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
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Sweden |Taipei :
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Warsaw |
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