Clinical Research Associate at Bristol-Myers Squibb

Seoul, South Korea, South Korea

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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

Understanding and proficiency working with targeted, centralized, remote and risk-based monitoring approaches
Strong analytical skills to evaluate site data and operational metrics, including ability to adjust monitoring strategies based on data trends and site performance
Effective communication skills, adapting to meet the needs of different stakeholders, utilizing the most appropriate communication style and method

Responsibilities

Conduct site qualification, initiation, routine monitoring and close-out visits across all trial phases in accordance with the Site Monitoring Plan, ensuring adherence to protocol, BMS Standard Operating Procedures (SOPs) and ICH GCP
Maintain the ethical and scientific integrity of clinical trials by verifying data within electronic systems and paper records (as applicable) to ensure the accessibility, completeness and accuracy of data submitted by study sites
Monitor site adherence to ICH GCP and local regulations, including compliance with the principles of ALCOA to maintain data integrity and reliability; where required, provide training and support to site staff to uphold these standards and ensure patient safety
Participate in sponsor and/or Health Authority audits and inspections as applicable
Cultivate and sustain effective relationships with internal cross-functional teams and external partners, including vendors, clinical sites, and key stakeholders; serve as the organization’s representative for clinical trials at the site level
Motivate and influence sites to meet study objectives, including enrollment and retention goals
Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
Assess potential Investigators and their sites to ensure sufficient resources and capabilities to conduct clinical trials; may identify new potential Investigators and/or sites through ongoing collaborations with internal and external stakeholders during the site feasibility and selection process
Identify, assess, and prioritize risks at the site and study level and support sites in mitigating issues, including implementing mitigation strategies based on risk indicators
Where applicable, perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor
Accountable for the review, reconciliation, and oversight of study drug/IMP; may support study drug/IMP label translation needs as applicable
Involvement in Regulatory Compliance audit/inspection process, as needed

Skills

ICH GCP

Clinical Trial Monitoring

Site Qualification

Site Initiation

Routine Monitoring

Site Close-out

ALCOA

SOPs

Protocol Adherence

Data Verification

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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