🏷️ Job Title: Global Trial Acceleration Associate
📍 Location: Hyderabad, Telangana, India
🕒 Employment Type: Full Time
🏢 Company: Bristol Myers Squibb (BMS)
🧭 Position Overview
The Global Trial Acceleration Associate manages and executes centralized activities to support global clinical trials, focusing on clinical documentation, regulatory submissions, and site start-up/activation. The role interacts with clinical study sites, CROs/vendors, Country Trial Managers (CTM)/Clinical Trial Monitors (CTMo), and cross-functional study teams, supporting all study phases: start-up, maintenance, and close-out.
⚙️ Key Responsibilities
Clinical Documentation & Trial Support
Act as main contact for essential document management, ethical/regulatory submissions, and study documentation.
Initiate and manage start-up documentation for global clinical trials.
Submit potential investigators to CTSS for debarment review and track decisions.
Manage country/site activation, including document review, checklist sign-off, and site activation.
Provide quality control support for start-up activities.
Maintain and track essential documentation throughout the study lifecycle.
Ongoing communication with study teams regarding centralized trial activities.
Arrange certified translation of study documentation (ICF, Protocol, IB) as required.
Assist in coordination/creation of study-specific materials (e.g., pharmacy files, investigator site files).
Support CSR distribution and country/site-level ICF adaptation.
Collect, review, and approve country and site-level documents.
Centrally review Site Monitoring Visit reports, escalate issues, and track resolution.
Create/manage standardized document templates as needed.
Perform other duties to support clinical trials.
Stakeholder & Vendor Management
Collaborate with internal and external stakeholders including CROs, vendors, CTMs, CTMos, and study teams.
Support outsourcing activities: selection, contracting, and execution of outsourced studies while ensuring compliance with regulatory standards, ethical practices, and BMS policies.
Systems & Process Management
Update and review clinical systems (CTMS, eTMF, SharePoint) to report trial document status.
Perform quality control of study documentation and eTMF.
🎓 Qualifications & Experience
Education
Bachelor’s degree in Life Sciences, Legal, Business Administration, or equivalent; advanced degree preferred.
Experience
Minimum 3 years in clinical development and operational experience in pharmaceutical, biotech, CRO, or related fields.
Preferably experienced as a field monitor (Clinical Research Associate) with global site monitoring report review experience.
Hands-on experience preparing, reviewing, and submitting regulatory documentation to IRB/IECs and Regulatory Agencies.
Experience in clinical study start-up/activation documentation and handling queries.
Knowledge of ICH/GCP and regulatory guidelines/directives.
Prior therapeutic area expertise (Oncology, Cardiology, Hematology, Immunology, etc.) preferred.
Skills & Competencies
Strong organizational, time-management, analytical, and decision-making skills.
Effective oral and written communication in English.
Proficiency in MS Office Suite, SharePoint, CTMS (Veeva Vault preferred), and other clinical trial enabling technologies.
Experience managing key internal and external stakeholders and cross-functional, multi-cultural teams.
Ability to manage multiple priorities, adapt to change, and sustain high performance in dynamic environments.
🌍 Work Environment & Culture
BMS promotes a supportive culture empowering employees to apply individual talents to clinical trial participation and patient outcomes.
Core values: Passion, Innovation, Urgency, Accountability, Inclusion, Integrity.
🏢 On-site Protocol
Site-essential: 100% onsite
Site-by-design: Hybrid (≥50% onsite)
Field-based/Remote-by-design: Travel as required for meetings, customers, and patients
⚖️ Equal Employment & Safety
BMS provides accommodations for people with disabilities.
Applicants with arrest or conviction records are considered per local laws.
Employees are strongly encouraged to maintain up-to-date COVID-19 vaccinations.
Recruitment data is processed according to privacy policies.
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Pondicherry (Puducherry) |Punjab :
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Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
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Frank Scottile Blvd |LA :
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Bangor | Brewer |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Rotherbaum :
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Halle |Schleswig Holstein :
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Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Galway |Meath :
Dunboyne |Republic of Ireland :
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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 :
South Yarra |New South Wales :
Ballina | Sydney |Queensland :
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Arkansas | Remote Australia |Republic of Western Australia :
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Amsterdam |Netherlands :
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Haarlem |North Brabant :
Breda |South Holland :
Leiden |North Yorkshire :
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Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Uxbridge | Mississauga | North York | Richmond Hill | Australia | Renfrew |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
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North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Paris | Lyon |Attica :
Athens | Koropi |Greece :
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Surabaya |Jakarta :
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Remote Korea |Republic of Korea :
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Rabigh | Jeddah | Najran | Riyadh | Khulais | King Abdullah Economic City |Nišava District :
Niš |Singapore :
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Sweden |Taipei :
Taipei |Williamson :
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Hà Nội | Hanoi |Ho Chi Minh :
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