ob Title: Senior Global Trial Acceleration Associate
Location: Hyderabad, Telangana, India
Company: Bristol Myers Squibb (BMS)
Company Overview
Bristol Myers Squibb (BMS) is a global biopharmaceutical company committed to transforming patients’ lives through science. BMS offers challenging, meaningful, and life-changing work across diverse therapeutic areas, promoting a culture of collaboration, inclusion, and innovation.
Job Overview
The Senior Global Trial Acceleration Associate manages and executes centralized activities supporting global clinical trials, focusing on clinical documentation, regulatory submissions, and site activation. This role interacts with clinical sites, IRBs/IECs, CROs, study teams, and other functional areas to ensure smooth trial start-up, maintenance, and close-out.
Key Responsibilities
Clinical Trial Start-Up & Documentation
Initiate and manage start-up documentation for global clinical trials.
Provide input on feasibility questionnaires and distribute/track responses.
Submit potential investigators to CTSS for debarment review.
Review essential regulatory documentation and resolve site issues.
Submit finalized documents to electronic Trial Master File (eTMF).
Activate sites/countries in compliance with study procedures.
Quality control of start-up activities as required.
Document Management & Regulatory Support
Maintain, update, and review study-related clinical systems (CTMS, eTMF).
Arrange certified translations of study documents.
Coordinate creation and management of study-specific materials (e.g., pharmacy files, ISF).
Serve as the single point of contact for centralized activities during study start-up.
Collect and track essential documentation; submit to Regulatory as needed.
Manage correspondence to investigative sites and coordinate IRB/IEC approvals.
Support submission of safety-related documents (SUSARs, DSURs, etc.).
Conduct QC of eTMF to ensure accuracy and completeness.
Lead or support global processes for Financial Disclosure Forms.
Assist with CSR distribution and informed consent adaptation/amendments.
Stakeholder Management & Collaboration
Build collaborative relationships with clinical investigator sites, study teams, CTM/CTMo., and vendors.
Interface with operational teams and service providers to ensure regulatory compliance and adherence to BMS policies.
Manage internal and external stakeholder communications effectively.
Other Responsibilities
Assist with creation/management of standardized document templates.
Perform additional duties as assigned to support clinical trials.
Qualifications & Experience
Bachelor’s degree in Legal, Life Sciences, Business Administration, or equivalent. Advanced degree preferred.
3–5 years of relevant clinical development and operational experience in Pharmaceutical, Biotech, CRO, or similar industries.
Hands-on experience preparing, reviewing, and submitting regulatory documentation to IRB/IECs and Regulatory Agencies.
Knowledge of ICH/GCP and regulatory guidelines; understanding of drug development processes.
Proficiency in MS Office Suite, SharePoint, and clinical trial management systems (CTMS, eTMF; Veeva Vault preferred).
Strong organizational, time-management, analytical, and decision-making skills.
Effective communication (written and oral) and ability to work in cross-functional, multi-cultural teams.
Proven ability to manage multiple priorities in a dynamic and evolving environment.
Work Environment & On-Site Requirements
May be site-essential, hybrid, field-based, or remote-by-design depending on role requirements.
Ability to travel to sites, customers, patients, or business partners as needed.
Equal Opportunity & Safety
BMS is committed to diversity, inclusion, and reasonable workplace accommodations.
Vaccination against Covid-19 is strongly recommended.
Employment is considered regardless of arrest/conviction records, in accordance with applicable law.
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 :
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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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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
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Digha | Kolkata | Mukundapur |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Goa :
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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 :
Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | Stanford | Stanton | St. Helena | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |New York :
Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |New Mexico :
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 :
Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |LA :
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 :
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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 :
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Boulder | Denver | Westminster |Connecticut :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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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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Bavaria |Bavaria :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Mitte |Mecklenburg Vorpommern :
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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 :
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Istanbul | Turkey |Norway :
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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 :
Uxbridge | North York | Renfrew | Mississauga | Australia | Richmond Hill |Canada :
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Montreal |Brussels :
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Peru | Argentina |Brazil :
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Auckland |New Zealand :
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Barcelona |Madrid :
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Croatia |Zagreb :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
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Surabaya |Japan :
Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
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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Buenos Aires |Republic of Egypt :
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New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
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 :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
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