Global Trial Acceleration Associate
Location: Hyderabad, Telangana, India
Employment Type: Full-time
Work Model: On-site
Category: Clinical Research / Clinical Operations
Requisition ID: R1595210
Role Overview
The Global Trial Acceleration Associate plays a critical role in supporting global clinical trials by managing centralized trial activities with a strong focus on clinical documentation, regulatory submissions, and site activation. This position collaborates closely with global study teams, CROs, clinical sites, and internal stakeholders to ensure timely, compliant, and efficient trial start-up, maintenance, and close-out activities.
This role is ideal for clinical operations professionals with hands-on experience in global study start-up, essential document management, and regulatory interactions, who thrive in a fast-paced, matrixed clinical research environment.
Key Responsibilities
Global Clinical Trial Support
Execute centralized activities supporting global clinical trials across all phases, including start-up, maintenance, and close-out.
Act as a primary point of contact for clinical documentation, regulatory, and ethics submission activities.
Maintain strong collaborative relationships with clinical sites, CROs, vendors, Country Trial Managers (CTMs), Clinical Trial Monitors (CTMos), and internal study teams.
Clinical Documentation & Systems Management
Initiate, collect, review, track, and maintain essential clinical trial documentation in compliance with ICH-GCP and regulatory requirements.
Update and monitor study status within clinical systems such as CTMS, eTMF, and vendor platforms.
Support quality control activities for study start-up documentation and site activation readiness.
Manage standardized document templates and assist with CSR distribution.
Regulatory & Ethics Submissions
Prepare, review, and submit documentation to IRBs/IECs and Regulatory Authorities, including responses to queries.
Coordinate certified translations of study documents such as Informed Consent Forms (ICFs), Protocols, and Investigator Brochures, as required.
Support country- and site-level ICF adaptation, review, and approval.
Site Activation & Start-Up Activities
Manage country and site activation activities, including final document review and checklist approvals.
Submit investigators for CTSS debarment review and track outcomes.
Ensure timely site activation in alignment with global and local study procedures.
Coordinate preparation of pharmacy files and investigator site files prior to site initiation visits or first patient visit.
Ongoing Trial Maintenance
Maintain continuous tracking of essential documents throughout the study lifecycle.
Provide ongoing communication and status updates to study teams regarding centralized trial activities.
Centrally review Site Monitoring Visit reports, escalate issues, and track follow-up actions.
Outsourcing & Vendor Support
Support outsourcing activities by interfacing with operational teams, service providers, and vendors.
Ensure outsourced study activities align with regulatory standards, ethical practices, and internal procurement policies.
Qualifications & Experience
Educational Qualification:
Bachelor’s degree in Life Sciences, Legal Studies, Business Administration, or a related field
Advanced degree is an advantage
Experience Required:
Minimum 3 years of relevant experience in clinical development or clinical operations within a pharmaceutical company, biotech organization, or CRO
Prior experience as a Clinical Research Associate (CRA) or field monitor with global site monitoring and report review experience is strongly preferred
Experience supporting global clinical trial start-up and activation activities is required
Technical & Professional Skills
Strong hands-on experience with regulatory and ethics submissions and start-up documentation
Solid understanding of ICH-GCP guidelines, global regulatory frameworks, and the drug development lifecycle
Proficiency with CTMS, eTMF, Veeva Vault (preferred), SharePoint, and MS Office applications
Experience working with clinical trial portals, databases, and enabling technologies
Strong organizational, analytical, and decision-making skills
Excellent written and verbal communication skills in English
Stakeholder & Project Management Skills
Proven ability to manage internal and external stakeholders in a global, matrixed environment
Experience working with cross-functional and multicultural teams
Strong time management skills with the ability to prioritize multiple initiatives simultaneously
High adaptability to ambiguous, fast-changing clinical research environments
Ability to sustain high performance under shifting priorities and tight timelines
Why Join This Role
This position offers the opportunity to contribute to life-changing clinical research within a globally respected organization, supporting trials that advance innovative therapies across multiple therapeutic areas including Oncology, Cardiology, Hematology, and Immunology.
Equal Opportunity & Data Protection
The organization is committed to equal employment opportunity, accessibility, and data privacy. Reasonable accommodations are available throughout the recruitment process. No fees or financial information are requested at any stage of hiring.
Gujarat :
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Germany | GErmany |Lower Saxony :
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China | Quarry Bay |Liaoning :
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Wuhan |Capital of Netherland :
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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 :
Renfrew | Uxbridge | Richmond Hill | Australia | North York | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
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Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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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 :
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Saitama | Japan |Tokyo :
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Najran | Jeddah | Rabigh | Khulais | King Abdullah Economic City | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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