Clinical Trial Monitor at Bristol-Myers Squibb

Shanghai, China

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Knowledge of clinical trial protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), ICH/GCP Guidelines, and applicable regulatory requirements
Ability to assess risks using data, identify issues, and make appropriate decisions
Ability to manage multiple protocols across multiple therapeutic areas
Willingness to travel based on assigned site location and/or geographic territory
Flexibility and adaptability in communication with different stakeholders
Skills in root cause analysis, corrective and preventive actions

Responsibilities

Identifies new potential Investigators through ongoing collaborations with internal and external stakeholders
Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials
Develops site relationships (including Contract Research Organization related issue management and non-registrational/Investigator Sponsored Research Studies)
Recommends sites during the site feasibility and/or site selection process
Conducts pre-study visits as appropriate
Conducts initiation visits to ensure Investigator and site personnel receive adequate protocol-specific training prior to site activation
Reviews site activities and quality through on-site and off-site visits; conducts monitoring activities and ensures safety and protection of study subjects per the monitoring plan, BMS procedural documents, protocol, ICH/GCP Guidelines, and local regulations
Performs Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor
Serves as a point of contact for sites
Provides trainings to sites
Performs site closure activities when all required protocol visits and follow-up are completed
Ensures completeness and quality of data submitted from study sites
Ensures eCRF data is available and current by using available systems to follow site activities; oversees activities of site personnel over whom there is no direct authority
Motivates/influences the site to meet study objectives, including enrolment and retention goals
Anticipates, identifies, and proactively supports sites in resolving issues; appropriately documents and escalates serious or persistent issues to management and project team; initiates, recommends, documents, and communicates corrective actions and follows up on implementation based on root cause analysis
Involved in Regulatory Compliance audit/inspection process as needed, including development and implementation of site corrective and preventive actions
Prepares (incomplete in provided description)

Skills

GCP

SOPs

Clinical Trial Monitoring

Site Feasibility

Site Selection

Investigator Assessment

Pre-Study Visits

Initiation Visits

Protocol Compliance

Regulatory Requirements

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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