Global Trial Associate (GTA)
Location: Hyderabad, Telangana, India
Job ID: R1602543
Company: Bristol Myers Squibb
Role Summary
The Global Trial Associate (GTA) supports the successful planning, execution, maintenance, and closeout of global clinical trials. Working closely with the Global Trial Lead (GTL) and cross-functional study teams, the GTA provides operational, project management, vendor management, documentation, and compliance support to ensure studies are conducted efficiently and in accordance with regulatory requirements.
Key Responsibilities
Clinical Trial Operations
Support the planning, execution, maintenance, and closure of global clinical studies.
Assist the Global Trial Lead (GTL) in driving study execution and operational activities.
Manage simple studies or studies in the closure phase under appropriate supervision.
Participate in study startup, maintenance, and closeout activities.
Support study-specific Clinical Study Report (CSR) appendices when required.
Project Management & Study Coordination
Utilize study performance metrics and quality indicators to monitor study progress.
Resolve routine operational issues and escalate critical risks appropriately.
Contribute as an active member of cross-functional study teams.
Support study-level planning tools, timelines, and operational processes.
Track study deliverables and ensure timely completion of assigned tasks.
Documentation & Compliance
Manage development, collection, and maintenance of study documentation.
Support eTMF completeness, quality, and inspection readiness.
Maintain study directories, SharePoint sites, and study communication channels.
Participate in filing activities and support audits and inspections as required.
Ensure compliance with ICH-GCP, regulatory requirements, and company SOPs.
Vendor & Financial Management
Coordinate vendor setup and payment processing activities.
Review vendor invoices and support approval workflows.
Manage study accruals, budget tracking, and Statement of Work (SOW) updates.
Maintain and monitor global vendor site lists.
Resolve vendor-related operational issues and escalate when necessary.
Risk & Issue Management
Identify study risks and operational challenges.
Develop mitigation plans and communicate concerns proactively.
Escalate significant issues to appropriate stakeholders.
Support continuous study oversight and quality management activities.
Meeting & Communication Support
Organize study team meetings and prepare agendas.
Capture and distribute meeting minutes and action items.
Manage study distribution lists and communication channels.
Collaborate with internal and external stakeholders to ensure smooth study execution.
Study Closure Activities
Lead assigned study closure and archival activities.
Ensure all study documentation is complete and archived appropriately.
Support final reconciliation and closeout requirements.
Required Qualifications
Education
Bachelor's degree in:
Life Sciences
Pharmacy
Clinical Research
Biotechnology
Nursing
Related Scientific Discipline
Experience
Experience in Clinical Trial Operations, Clinical Research, or Clinical Project Support.
Understanding of global clinical trial processes and study lifecycle management.
Experience supporting cross-functional clinical study teams.
Exposure to study documentation and trial management systems is preferred.
Technical Skills
Knowledge of clinical trial operations and study management.
Understanding of ICH-GCP guidelines and regulatory requirements.
Study documentation and eTMF management.
Vendor management and payment processing.
Clinical trial tracking and reporting.
Basic project management knowledge.
Core Competencies
Strong organizational and multitasking skills.
Excellent communication and stakeholder management abilities.
Attention to detail and compliance focus.
Problem-solving and risk identification skills.
Ability to work independently while seeking guidance when needed.
Flexibility to adapt to changing priorities and business needs.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tamil nadu | Tiruchirappalli | tiruppur | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
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Bhubaneswar | Rourkela |Chhattisgarh :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | Gangtok | 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 | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
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Bangor | Brewer |New Jersey :
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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
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Concord | Lumberton | North Carolina |Michigan :
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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Lisbon | Oeiras | Portugal |WI :
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Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
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Gottingen | Hannover | Leipzig |Saxony Anhalt :
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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 :
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Wuhan |Capital of Netherland :
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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 :
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Canada |Quebec :
Montreal |Brussels :
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Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
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Auckland |New Zealand :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Seoul |Kazakhstan :
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Bangkok |Israel :
Be'Er Sheva | Yavne | Netanya | Kfar Saba | Tel Aviv |Remote :
Green Way | Medan | Minnesota | Remote - Middle East | Victoria | Hungary | Riga | Lenexa | Melbourne | Hammond | Blue Bell | Manipal | Perth | Ireland | Remote - Africa | Castlebar | Slovakia | Lousiana | Bishop | Bountiful | Xzagreb | Belgium | Leinster | Faridabad | Springville | Switzerland | Nairobi | Remote - Europe | Tulsa | Remote - South America (Latin Americal) | Zaragoza | McFarland | Thailand | Milwaukee | Texas | Regulatory Labeling Manager (NA and LATAM Only) | French |Republic of Colombia :
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New Mexico | Ciudad de México |Dubai :
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Najran | Riyadh | King Abdullah Economic City | Rabigh | Khulais | Jeddah |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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