Company Overview
ICON plc is a world-leading healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, medical device, and public health organizations in advancing clinical development and improving patient outcomes.
Job Details
|
Category |
Details |
|---|---|
|
Job Title |
Site Specialist II |
|
Company |
ICON plc |
|
Location |
Chennai |
|
Work Mode |
Office with Flex |
|
Department |
Site Activation / Clinical Operations |
|
Industry |
Clinical Research / Pharmaceutical / Biotechnology |
|
Employment Type |
Full-Time |
|
Experience Required |
3+ Years |
|
Education Required |
Bachelor’s Degree |
|
Preferred Field |
Life Sciences, Business, or Related Discipline |
Role Summary
The Site Specialist II supports clinical trial site activation, maintenance, and contract management activities. The role involves coordinating study start-up processes, handling essential documentation, supporting ethics submissions, managing informed consent workflows, and assisting with site contracts and amendments.
The position requires collaboration with global cross-functional teams to ensure clinical trial sites are activated and maintained in compliance with regulatory and operational requirements.
Key Responsibilities
1. Study Start-Up Activities
Support clinical study start-up activities.
Review and manage essential study documents.
Coordinate:
Green light process management
Site activation readiness
Ensure study timelines are achieved efficiently.
2. Site Maintenance & Documentation
Customize site-specific Informed Consent Forms (ICFs).
Coordinate document translation activities.
Support:
EC (Ethics Committee) submissions
IRB (Institutional Review Board) submissions
Maintain and document records in eTMF systems.
3. Contract Management
Assist with:
Site contract workflows
Contract amendments
Contract negotiations
Ensure timely execution and finalization of agreements.
Support compliance with contractual and operational requirements.
4. Cross-Functional Collaboration
Work closely with:
Clinical Operations
Regulatory teams
Legal teams
Sponsors
Global project teams
Ensure coordination across departments to meet project timelines.
5. Communication & Stakeholder Management
Communicate effectively with internal and external stakeholders.
Provide clear written and verbal updates.
Maintain professional relationships across global teams.
6. Operational Flexibility
Work flexible shifts/hours to support global operations and team requirements.
Required Qualifications
Educational Requirements
Bachelor’s Degree in:
Life Sciences
Business
Related field
Experience Requirements
Minimum 3 years of experience in:
Clinical trial start-up
Site maintenance activities
Contract management
Clinical research operations
Technical & Functional Skills
Knowledge Areas
Study start-up processes
Site activation workflows
Contract management
ICF customization
Translation workflows
IRB/EC submissions
eTMF systems
Preferred Experience
Contract negotiations
Clinical site documentation management
Global clinical operations support
Soft Skills
Strong organizational skills
Attention to detail
Ability to manage multiple priorities
Strong interpersonal skills
Effective written and verbal communication
Collaboration across global teams
Time management and adaptability
Preferred Candidate Profile
Ideal candidates may have experience in:
Site Activation
Clinical Trial Start-Up
Regulatory Documentation
eTMF Management
Clinical Operations
Site Contracts
IRB/EC Submissions
Informed Consent Management
CRO environments
Pharmaceutical or Biotechnology industries
Benefits Offered
Compensation & Rewards
Competitive salary package
Recognition and performance programs
Health & Wellbeing
Comprehensive health insurance options
Employee Assistance Programme (TELUS Health)
Life assurance coverage
Wellness initiatives
Work-Life Balance
Annual leave entitlements
Flexible employee benefits
Hybrid/flexible work environment
Family-focused support programs
Financial & Lifestyle Benefits
Retirement planning programs
Childcare vouchers
Bike purchase schemes
Discounted gym memberships
Subsidized travel passes
Health assessments
Diversity & Inclusion
ICON plc is committed to maintaining an inclusive and accessible workplace and provides equal employment opportunities regardless of:
Race
Religion
Gender
Sexual orientation
Gender identity
National origin
Disability
Veteran status
Reasonable accommodations are available during the recruitment and employment process
Uttar Pradesh :
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Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
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 | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Baton Rouge | Monroe | New Orleans |Washington :
Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
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 :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
Charleston |Kansas :
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 :
Richmond Hill | North York | Australia | Renfrew | Uxbridge | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |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 :
Almaty |Republic of Thailand :
Bangkok |Israel :
Netanya | Be'Er Sheva | Kfar Saba | Tel Aviv | Yavne |Remote :
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Bogota |Williamson :
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Buenos Aires |Republic of Egypt :
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New Mexico | Ciudad de México |Dubai :
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Najran | Khulais | Riyadh | Rabigh | Jeddah | King Abdullah Economic City |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
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