Global Trial Acceleration Associate at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Minimum of a bachelor’s degree in legal, life science, business administration, or equivalent experience
Advanced degree a plus

Responsibilities

Managing and executing centralized activities in support of global trials with an emphasis on clinical documentation
Interacting with clinical study sites, CROs/vendors, Country Trial Managers (CTM)/Clinical Trial Monitors (CTMo.), the study team, and other functional areas within BMS
Providing support to the Study Team throughout the study duration (start-up, maintenance, and close-out of clinical studies)
Acting as the main point of contact for essential document management, ethical and regulatory submission-related activities, and developing/maintaining collaborative working relationships with relevant stakeholders
Supporting 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/procedures
Initiating and managing start-up documentation activities for global clinical trials
Submitting potential investigators to CTSS for debarment review and tracking decisions
Responsible for country/site activation for clinical trials as applicable per region, including final review of applicable documents, final sign-off of the country/site activation checklist, and activating the site in accordance with all applicable global/local study procedures
Providing a level of quality control of start-up activity
Updating and reviewing various study-related clinical systems (e.g., CTMS, eTMF, or corresponding vendor systems) to determine and report status of clinical trial documents for insourced studies
Arranging certified translation of study level documentation from translators as requested (e.g., ICF, Protocol, IB)
Assisting with the coordination or creation of other study-specific materials such as pharmacy or Investigator site file to ensure availability on site for site initiation visits/prior to first patient visit
Acting as single point of contact for the study team for centralized activities during study start-up
Performing ongoing maintenance and tracking of essential documentation, collection of updated/outstanding documentation, and submission as required during all phases of clinical trial
Conducting ongoing communication with study teams regarding centralized study activities
Responsible for creation and management of standardized document templates
Assisting with CSR distribution
Handling country and site level ICF adaptation
Performing essential document collection, review, and approval of country and site level documents
Centrally reviewing all Site Monitoring Visit reports, issue escalation, resolution, and follow-up tasks
Other duties as assigned to support Clinical Trials

Skills

clinical documentation

essential document management

regulatory submissions

clinical trial management

CRO management

vendor management

outsourcing

stakeholder management

study start-up

study maintenance

study close-out

compliance

ethical practices

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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