Job Description: Country Approval Specialist
Work Schedule
Type: Standard (Mon-Fri)
Environmental Conditions: Office-based
Purpose
Join Thermo Fisher Scientific Inc. and make an impact on global clinical research by becoming a Country Approval Specialist in our PPD clinical trial team. This is an excellent opportunity to contribute to world-class clinical trials and ensure their successful initiation across various countries.
Key Responsibilities
Clinical Trial Submissions:
Prepare and submit trial documents to competent authorities and ethics committees, ensuring compliance with local regulations.
Gather and organize all essential documents required for the trial and research sites.
Site Activation Management:
Review and prepare Investigational Product (IP) greenlight packages and collaborate with study teams to ensure site activation readiness.
Drive timely activation of clinical trial sites, ensuring that all activations comply with regulatory standards.
Collaboration and Coordination:
Work closely with research sites, regulatory teams, and clinical operations teams to ensure smooth implementation of trial activation plans.
Maintain close communication with cross-functional teams to resolve any potential barriers to trial activation promptly.
Documentation and Compliance:
Ensure meticulous documentation of all trial activation processes and approvals.
Monitor the status of clinical trial site activations and manage any challenges that arise.
Issue Resolution:
Proactively identify potential issues related to site activation and collaborate with relevant teams to find effective solutions.
Education and Experience
Educational Background: Bachelor’s degree or equivalent experience in Life Sciences, Pharmacy, or a related field.
Experience: Proven experience in clinical trial management, study startup activities, or a related research role is preferred.
Skills and Abilities
Attention to Detail: Strong ability to manage multiple tasks while maintaining a high standard of accuracy.
Organizational Skills: Excellent organizational skills to keep track of various site activation processes and documentation.
Collaboration: Ability to work effectively in a team-oriented environment, collaborating with diverse groups to meet project goals.
Regulatory Knowledge: Understanding of clinical trial requirements, regulatory standards, and GCP guidelines.
Communication Skills: Excellent verbal and written communication skills for interacting with cross-functional teams, research sites, and regulatory bodies.
Technical Proficiency: Familiarity with clinical trial management systems and regulatory requirements.
Why Thermo Fisher Scientific?
At Thermo Fisher Scientific, you will contribute to an organization that supports global health initiatives and scientific innovation. By joining our team, you will have the opportunity to make a meaningful impact on clinical trials and the lives of people around the world.
If you are passionate about clinical research and eager to be part of a dynamic and innovative team, apply now and help us advance our mission of making the world healthier, cleaner, and safer.
For more information and to apply, visit Thermo Fisher Careers.
Equal Opportunity Employer: Thermo Fisher Scientific is committed to diversity and inclusion. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
Gujarat :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Odisha :
Bhubaneswar | Rourkela |Chhattisgarh :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Uttar Pradesh :
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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 :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Texas :
Abilene | Arlington | Austin | Boerne | Brenham | Bulverde | Carrollton | Cedar Hill | Corpus Christi | Corsicana | Dallas | Denton | El Paso | Fort Worth | Garland | Houston | Lakeway | Longview | Mcallen | North Richland Hills | Plano | Richardson | San Antonio | Seguin | Tyler | Waco |California :
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Albuquerque | Farmington | Santa Fe | Tucumcari |Pennsylvania :
Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Pottstown | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |Alaska :
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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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 :
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Frank Scottile Blvd |Missouri :
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Arkansas | Remote Australia |New South Wales :
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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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Japan | Saitama |Tokyo :
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Seoul |Kazakhstan :
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Bangkok |Israel :
Kfar Saba | Netanya | Tel Aviv | Yavne | Be'Er Sheva |Remote :
Lenexa | Green Way | Remote | Remote - South America (Latin Americal) | Xzagreb | Tulsa | Switzerland | Bountiful | McFarland | Medan | Texas | Manipal | French | Minnesota | Castlebar | Remote, USA | Remote - Middle East | Leinster | Slovakia | Lousiana | Ireland | Remote - Europe | Melbourne | Belgium | Hungary | Nairobi | Thailand | Bishop | Riga | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Africa | Faridabad | Springville | Blue Bell | Victoria | Zaragoza | Hammond |Republic of Colombia :
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Khulais | King Abdullah Economic City | Riyadh | Jeddah | Najran | 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 :
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