Senior Clinical Trial Manager at Bristol-Myers Squibb

Buenos Aires City, Buenos Aires Autonomous City, Argentina

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Experience in clinical trial management or equivalent role at a senior level
Ability to act as primary point of contact for internal and external stakeholders at country level
Knowledge of clinical trial processes, including feasibility, start-up, recruitment, and risk management
Proficiency with Clinical Trial Management System (CTMS), eDC, eTMF, and related systems
Skills in vendor assessment and setup
Capability to lead problem-solving, issue resolution, and escalation

Responsibilities

Acts as the main point of contact for a country with global study team members and coordinates with local country cross-functional teams
Implements the local country and site feasibility process, including proposal and validation of country study targets, as endorsed by country leadership
Plans, develops, and executes timelines and activities for start-up in collaboration with the local study team, Global Trial Acceleration Centre (GTAC), and other relevant stakeholders
Implements country and site level patient recruitment strategy and risk mitigation; coordinates to ensure country level study enrolment targets and timelines are met
Leads problem-solving and resolution efforts, including management of risk, contingencies, issue resolution, and escalation to appropriate stakeholders
Assesses and sets up vendors during study start-up period (locally)
Participates in and prepares for Investigator Meetings
Ensures data entered in the Clinical Trial Management System (CTMS) is current and complete, and access to eDC and vendor systems is available for country and site personnel; enters necessary data and uploads documents in eTMF
Validates study-related materials (e.g., protocol, ICF, patient material)
Supports review of country and site-specific documents (e.g., ICF, patient material), and prepares site-level ICF and other documents where applicable
Supports preparation of materials for Site Initiation Visits
Verifies and confirms eTMF completeness at country and site level with local team
Prepares investigator sites to conduct clinical trials by verifying acceptability of Clinical Trial Package (CTP) documentation
Acknowledges Site Monitoring visit reports, takes action within specified timelines, and escalates issues

Skills

Clinical Trial Management

Study Oversight

Stakeholder Management

Project Coordination

Timeline Management

Budget Management

Quality Standards

Cross-Functional Coordination

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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