Job Title: Senior Study Site Specialist
Location: Canada (Remote)
About ICON plc:
ICON plc is a leading global healthcare intelligence and clinical research organization. We are committed to fostering an inclusive environment, driving innovation and excellence in clinical development.
Role Summary:
ICON is seeking a Senior Study Site Specialist to join our team. In this role, you will be responsible for managing the end-to-end process of site management, from feasibility to site activation. Serving as the primary point of contact between the site and the study team, you will be integral in coordinating site identification, feasibility assessments, site qualification, and supporting all start-up, maintenance, and close-out activities for clinical trials.
Key Responsibilities:
Oversee the end-to-end site management process, serving as the primary point of contact for sites and study teams.
Support site feasibility assessments, including the negotiation and collection of Confidential Disclosure Agreements and Feasibility Questionnaires.
Oversee site contract and budget negotiations, including Clinical Trial Agreements, Confidentiality Agreements, and Ancillary Agreements.
Manage the collection, tracking, and review of essential documents to ensure compliance.
Assist in the development of in-house model process documents and study procedures.
Support Ethics Committee and Regulatory Authority submissions.
Manage country-specific and site-specific activities, such as obtaining necessary licenses and approvals for study activation.
Lead In-House Study team meetings and participate in Study Management meetings.
Utilize tracking tools to monitor study activities and prepare reports.
Qualifications:
Bachelor’s Degree in Business Administration, Finance, Science, or a related field.
Minimum of five years of relevant experience in the biopharmaceutical/CRO industry.
Global experience, including familiarity with US and EU regulations.
Strong organizational and multitasking abilities, with the ability to prioritize effectively.
Proactive problem-solver with the ability to identify issues and propose solutions.
Detail-oriented with excellent interpersonal skills.
Proficient in Veeva Vault and Microsoft Office applications.
Ability to manage ambiguous situations and make decisions based on available information.
Work Arrangement:
Remote position with flexibility.
Compensation & Benefits:
Competitive salary based on experience and qualifications.
Comprehensive health insurance options tailored to support you and your family.
Retirement planning tools and options for long-term financial stability.
Global Employee Assistance Programme (TELUS Health), offering 24/7 access to mental, emotional, and physical well-being services.
Life assurance and flexible, country-specific benefits such as:
Childcare vouchers
Bike-to-work schemes
Discounted gym memberships
Health assessments
Subsidized public transport
Diversity & Inclusion:
ICON is committed to providing an inclusive and accessible environment for all candidates. We ensure equal employment opportunities regardless of race, religion, gender, sexual orientation, gender identity, national origin, disability, or veteran status.
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Baddi | Solan |India :
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B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
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Birmingham |Alaska :
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Wilmington |Florida :
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Boise |Illinois :
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Garden city | Kansas City | Lawrence | McPherson |Kentucky :
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Frank Scottile Blvd |LA :
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Bangor | Brewer |Maryland :
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Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |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 | New Brunswick | Newark | 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 | West Orange | Westfield | Wharton | Whippany |New Mexico :
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Wavre |BULGARIA :
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Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
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Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
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Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
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Leiden |North Yorkshire :
Harrogate |Oxfordshire :
Witney |South Yorkshire :
Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Renfrew | Mississauga | Richmond Hill | North York | Uxbridge |Quebec :
Montreal |Chile :
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Croatia |Zagreb :
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Cairo |Estonia :
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North Ostrobothnia :
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Turku |France :
Lyon | Paris |Attica :
Koropi | Athens |Greece :
Greece |East Java :
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Jakarta |Israel :
Kfar Saba | Yavne | Tel Aviv | Be'Er Sheva | Netanya |Italy :
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Rho |Japan :
Japan | Saitama |Tokyo :
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Almaty |Remote Korea :
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Ciudad de México |North Island :
Auckland |Lima Region :
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Warsaw |Remote :
Remote, USA | Switzerland | Remote | Remote - Europe | Remote - South America (Latin Americal) | Melbourne | Remote - Africa | Remote - Middle East | McFarland | Lenexa |Bucharest :
Bucharest |Makkah :
Jeddah | Riyadh | Rabigh | King Abdullah Economic City | Khulais | Najran |Nišava District :
Niš |Singapore :
Singapore |South Africa :
Midrand | South Africa |Brazil :
Sao paulo | Brazil |South America :
Peru | Argentina |Catalonia :
Barcelona |Madrid :
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Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
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Ho Chi Minh City |