Global Trial Acceleration Associate

Overview

Global Trial Acceleration Associate managing and executing centralized activities in support of global clinical trials, with an emphasis on clinical documentation, across study start-up, maintenance and close-out.

What you'll do

• Act as the main point of contact for essential document management and ethical and regulatory submission-related activities.
• Develop and maintain collaborative working relationships with relevant stakeholders, including clinical study sites, CROs/vendors, Country Trial Managers (CTM)/Clinical Trial Monitors (CTMo.), the study team and other functional areas within BMS.
• Support outsourcing activities by interfacing with operational teams, support groups and service providers for selection, contracting and execution of outsourced studies, ensuring compliance with regulatory standards, ethical practices, BMS outsourcing and procurement policies and procedures.
• Initiate and manage start-up documentation activities for global clinical trials.
• Submit potential investigators to CTSS for debarment review and track decisions.
• Be responsible for country/site activation for clinical trials as applicable per region, including final review of applicable documents and final sign-off of the country/site activation checklist.
• May activate sites in accordance with applicable global/local study procedures and provide a level of quality control of start-up activity.
• Update and review study-related clinical systems to determine and report status of clinical trial documents for insourced studies (e.g., CTMS, eTMF, or corresponding vendor systems).
• May arrange certified translation of study-level documentation (e.g., ICF, Protocol, IB).
• May coordinate or create study-specific materials such as pharmacy or investigator site files so they are available on site for site initiation visits or prior to first patient visit.
• May act as single point of contact for the study team for centralized activities during study start-up.
• Maintain and track essential documentation, collect updated and outstanding documentation, and submit as required throughout all phases of the clinical trial.
• Communicate ongoing with study teams regarding centralized study activities.
• May create and manage standardized document templates.
• Assist with CSR distribution, country and site-level ICF adaptation, and essential document collection, review and approval of country and site-level documents.
• Centrally review all Site Monitoring Visit reports, handling issue escalation, resolution and follow-up tasks.
• Perform other duties as assigned to support clinical trials.

What you'll need

• Minimum of a bachelor's degree in legal, life science, business administration, or equivalent experience.
• Minimum 3 years of relevant clinical development and operational experience in pharmaceutical, biotech, CRO or similar fields.
• Hands-on experience preparing, reviewing and submitting regulatory documentation to IRB/IECs and regulatory agencies, including formulating responses to queries.
• Hands-on experience preparing, reviewing and submitting clinical study start-up/activation documentation, including responses to queries.
• Knowledge of ICH/GCP and regulatory guidelines/directives, and understanding of the drug development process and pharma.
• Strong organizational, time-management, analytical and decision-making skills to efficiently evaluate, plan and accomplish work goals.
• Effective communication skills in English (written and oral) and computer skills including MS Office suite and SharePoint.
• Proven experience managing key internal and external stakeholders by soliciting input and incorporating feedback into processes.
• Effective management or support of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure.
• Proven time management skills and flexibility to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts.
• High level of adaptability in dealing with ambiguous and complex work environments, balancing multiple demands in a responsive and professional manner.
• Ability to sustain high levels of performance in a constantly changing environment.

Nice to have

• Advanced degree.
• Seasoned field monitor with minimum 3+ years of global site monitoring (Clinical Research Associate) report review experience.
• Prior therapeutic area expertise (e.g., Oncology, Cardiology, Hematology, Immunology).
• Veeva Vault experience, and knowledge of portals, databases and other clinical trial enabling technologies (CTMS).

Details

• Location: Hyderabad, Telangana, India.
• Work model is assigned based on core responsibilities (site-essential, site-by-design, field-based or remote-by-design).