Global Trial Acceleration Associate at Bristol Myers Squibb

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

04 Feb, 26

Salary

0.0

Posted On

06 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Documentation, Regulatory Submission, Stakeholder Management, Project Management, Quality Control, Communication Skills, Organizational Skills, Analytical Skills, Time Management, Clinical Trial Management, GCP Knowledge, Pharmaceutical Experience, CRO Experience, Document Management, Team Collaboration, Adaptability

Industry

Pharmaceutical Manufacturing

Description

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Key Responsibilities The Global Trial Acceleration Associate is responsible for managing and executing on centralized activities in support of global trials with an emphasis on clinical documentation. The Global Trial Acceleration Associate will interact with clinical study sites, CROs/vendors, Country Trial Managers (CTM)/Clinical Trial Monitor (CTMo.), the study team and other functional areas within BMS and will provide support to the Study Team throughout the study duration (start-up, maintenance, and close-out of clinical studies). As the main point of contact for essential document management, ethical and regulatory submission-related activities, develops and maintains collaborative working relationships with relevant stakeholders. Support outsourcing activities by interfacing with operational teams, support groups and service providers for successful selection, contracting and execution of outsourced studies while 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. Submission of potential investigators to CTSS for debarment review and tracking of decisions. Responsible for country/Site Activation for clinical trials as applicable per region; this includes the final review of applicable documents, final sign-off of the country/site activation checklist. The incumbent may also be responsible for activating the site in accordance with all applicable global / local study procedures. May provide a level of quality control of start-up activity. Update and review of various study-related clinical systems to determine and report status of clinical trial documents for insourced studies (i.e., CTMS, eTMF, etc. or corresponding vendor systems) May arrange certified translation of study level documentation from translators as requested (i.e., ICF, Protocol, IB) May assist with the coordination or creation of other study specific materials such as pharmacy or Investigator site file to ensure that these are available on site for site initiation visits/prior to first patient visit. May act as single point of contact for the study team for centralized activities during study start-up. Ongoing maintenance and tracking of essential documentation and collection of updated/outstanding documentation and submission as required during all phases of clinical trial. Ongoing communication with study teams regarding centralized study activities. Maybe responsible for creation and management of standardized document templates. Assist with CSR distribution Country and site level ICF adaptation. Essential document collection, review and approval of country and site level documents. Centrally reviewing all the Site Monitoring Visit reports, issue escalation, resolution and follow up tasks. Other duties as assigned to support Clinical Trials. Qualifications & Experience Minimum of a bachelor’s degree in legal, Life science, Business Administration, or equivalent experience. Advanced degree a plus. Minimum 3 years of relevant clinical development & operational experience in Pharmaceutical, biotech, CRO or similar fields, is required. Seasoned field monitor with min 3+ years of global site monitoring (Clinical Research Associate) report review experience is preferred. Prior therapeutic area expertise (eg: Oncology, Cardiology, Hematology, Immunology etc) is preferred. Hands-on experience preparing, reviewing, and submitting regulatory documentation to IRB/IECs and Regulatory Agencies; including formulating responses to queries. Hands-on experience of preparing, reviewing, and submitting clinical study start-up / activation documentation, including responses to queries. Knowledge of ICH / GCP and regulatory guidelines/directives, understanding of 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 & oral), computer skills - MS office suite, SharePoint, etc. CTMS (Veeva Vault experience preferred, knowledge of portals, databases and other Clinical Trial enabling technologies Proven experience in managing key internal and external stakeholders effectively by frequently soliciting input and gathering and incorporating feedback into processes as appropriate. 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 ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts. Demonstrates a high level of adaptability in dealing with ambiguous and complex work environment and balances multiple demands on role in a responsive and professional manner. Ability to sustain high levels of performance in a constantly changing environment. If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

Responsibilities

The Global Trial Acceleration Associate manages and executes centralized activities in support of global trials, focusing on clinical documentation. They interact with various stakeholders and support the study team throughout the study duration, ensuring compliance and effective communication.