Associate Global Trial Manager at Bristol-Myers Squibb

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

(Not explicitly listed in the provided job description)

Responsibilities

Supports study execution utilizing available performance metrics and quality indicators
May oversee clinical monitoring quality and adherence to established processes and plans
Supports/manages discrete study deliverables (e.g., timelines, study plans, CTMS) through collaboration with internal and external stakeholders to inform robust data driven decisions
Proactively identifies potential risks, supports Global Trial Lead (GTL) in development/implementation of actions, and contributes to discussions on balancing risks with study deliverables and costs. (Manages development and implementation if Principal GTA is study lead.)
Solves routine problems/issues; escalates to GTL or other related functions as needed
Informs lead GTL and other leadership on overall clinical trial plans and potential issues/mitigation
Exposure to situations where benefit-risk and issues assessments need to be managed
Supports creation and implementation of project management tools at study level (issues log and risk management plan – drives tool maintenance)
Manages the development/set-up and/or collection of study level documentation and supports GTL in ensuring eTMF accuracy, completion and ongoing quality
Supports GTL's review of study documents (e.g., synopsis, protocol, ICF, CRFs, CRF completion guidelines, Study Execution plans, Clinical Data Review Plan, Clinical Database edit specification, CSR). (Performs these tasks if Principal GTA is study lead.)
Supports country and site feasibility/selection processes with use of robust data
May support the development of the subject recruitment/retention strategy and related initiatives
Oversees/supports study specific CSR appendices, as needed
Supports GTL in providing input and communicating with teams for response to country/regulatory IRB/IEC
Assists with data, protocol deviation review, and study level trackers
Participates in Audit Response Team, CAPA, and inspections
May be responsible for managing certain company-sponsored study types from start-up through close-out (e.g., NPP, HEOR, with patients)
Reviews vendor invoices and leads approval process or submits to GTL for approval; manages accruals and LSD/SOW changes
Provides input to the development/management of the vendor scope of work/LSD per contract, quality, and budget under supervision of GTL and outsourcing manager
Reviews the study budget worksheet for completeness and accuracy
Participates in updating financial forecasting and supports GTL with financial reconciliation activities

Skills

Project Management

Clinical Trial Management

Risk Management

Stakeholder Collaboration

CTMS

Study Execution

Performance Metrics

Global Trial Lead

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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