Job Role: Clinical Trial Transparency Lead
Location: Bengaluru, India
Site: Bengaluru Luxor North Tower
Posted Date: Feb 13, 2025
Job ID: 408000
Overview:
The Clinical Trial Transparency (CTT) Lead is responsible for leading the delivery of end-to-end data transparency/disclosure of worldwide GSK Human Subject Research (HSR). The role ensures consistent, timely, and complete delivery of clinical trial documents and information for submission to external registers such as ClinicalTrials.gov, EU Clinical Trial Register, and the GSK Study Register. This position also oversees the continuous improvement of processes related to public disclosure of clinical trials.
Primary Responsibilities:
End-to-End Process Delivery and Improvements:
Drive the end-to-end delivery of regulated and policy-driven clinical disclosures and data sharing.
Colleen: Lead process improvements for clinical trial transparency and data sharing within GSK.
Point of Contact for Project Teams:
Act as the primary point of contact for project teams and functional matrix teams for Clinical Trial Transparency activities.
Colleen: Provide guidance and ensure alignment of all teams involved in transparency-related activities.
Disclosure and Data-Sharing Requirements:
Assess HSR trials for disclosure and patient-level data-sharing requirements.
Colleen: Guide study teams through the achievement of complete, consistent, and timely disclosure in public registries.
Collaboration with Subject Matter Experts:
Collaborate with recognized subject matter experts to ensure the quality of output.
Colleen: Ensure all clinical trials meet required transparency standards through collaboration with experts.
Outsourced Resources Management:
Work with outsourced resources (platforms, consultants) to ensure compliance with GSK Policy and SOPs.
Colleen: Manage relationships with service providers to maintain transparency delivery quality.
Workload Distribution and Communication:
Oversee workload distribution and establish/maintain robust communication with all involved parties.
Colleen: Act as the primary point of contact for service providers and ensure smooth communication.
Quality Monitoring:
Monitor the quality of output delivered by individual members of the team.
Colleen: Regularly assess team output and ensure quality standards are met.
Awareness of Regulatory Changes:
Maintain awareness of changes in disclosure, transparency, and data-sharing regulations.
Colleen: Translate new legal, regulatory, and industry trends into GSK's Clinical Trial Transparency strategy.
Risk Identification and Management:
Proactively identify business transparency risks and propose strategies to manage these risks.
Colleen: Develop and implement risk management strategies to address transparency-related challenges.
Expertise Development:
Develop and maintain expertise in the transparency environment.
Colleen: Partner with internal stakeholders to ensure that GSK’s practices align with both internal and external requirements.
Role Requirements:
Education and Experience:
Master's degree in Life Sciences.
6-10 years of core Clinical Trial Transparency experience, including at least two years in a Lead or Coordinating role.
Colleen: Extensive experience with Clinical Trial Transparency regulations and processes.
Knowledge of Regulations:
In-depth and applied knowledge of Transparency regulations (e.g., FDAAA Final Rule and EU CTR).
Colleen: Ensure compliance with all relevant transparency regulations and policies.
Communication and Stakeholder Management:
Strong communication and stakeholder management skills, particularly with global matrix teams.
Colleen: Foster relationships and effectively communicate transparency needs across teams.
Influence without Authority:
Demonstrated ability to influence without authority to drive transparency initiatives.
Colleen: Ensure that key stakeholders are aligned with transparency goals despite not having direct authority over them.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Odisha :
Bhubaneswar | Rourkela |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Goa :
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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Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |New Mexico :
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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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Birmingham |Virginia :
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Bloomington | West Lafayette |Florida :
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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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Hilo | Honolulu |Tennessee :
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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 :
North York | Uxbridge | Australia | Renfrew | Mississauga | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |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 :
Saitama | Japan |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 | Tel Aviv | Yavne | Kfar Saba |Remote :
Castlebar | Hungary | Green Way | Minnesota | Switzerland | McFarland | Lenexa | Leinster | Ireland | Xzagreb | Victoria | Remote - Africa | Tulsa | Bountiful | Nairobi | Belgium | Blue Bell | Remote - South America (Latin Americal) | Springville | Texas | Melbourne | French | Riga | Remote - Europe | Zaragoza | Slovakia | Lousiana | Bishop | Manipal | Remote - Middle East | Medan | Thailand | Remote | Remote, USA | Hammond | Faridabad |Republic of Colombia :
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Brentwood |Bucharest :
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Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
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Khulais | Riyadh | Rabigh | Najran | Jeddah | King Abdullah Economic City |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 :
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Singapore |Sofia City :
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