Senior CRA at Bristol-Myers Squibb

Shanghai, China

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Bachelor’s degree required, preferably within life sciences or equivalent
5 years of monitoring experience as a Senior Clinical Research Associate (preferred, but a combination of monitoring and relevant clinical research experience can be considered)
Demonstrates leadership attributes and capability to take on mentor/coach role
Extensive experience and demonstrated strong performance in all aspects of the role

Responsibilities

Act as point of contact for Sites
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 through the review and approval of essential clinical trial and regulatory documents
Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission
Manage the end-to-end process for executing Clinical Trial Agreements (CTAgs) with investigator sites
Prepares contract documents from templates and modify to reflect unique aspects of the particular study, including the CTAg financial appendix
Negotiates financial and legal aspects of CTAg and Master Service Agreements with sites, Institutions or vendor personnel
Prepare country Informed Consent Form (ICF) and manage country ICF template, review and approval of Site ICFs
Review and approval of Clinical Trial Package (CTP) documentation
Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management
Update national registries as applicable
Prepare materials for Site Initiation Visits
Conduct support Investigator Site Assessment Visits (ISAs) and Site Initiation Visits (SIVs)
Conduct site qualification, initiation, routine monitoring and close-out visits, including post-close out across all trial phases in accordance with the Site Monitoring Plan, ensuring adherence to protocol, BMS Standard Operating Procedures (SOPs) and ICH GCP
Perform submission to Site Ethics Committees and Site GCP Institution, including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission). Coordinate the Site Ethics Committees and Site GCP Institution responses with study teams
Collect and distribute documents to and from sites including obtaining insurance certificates
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

Skills

Clinical Monitoring

Site Management

Feasibility Assessment

Clinical Trial Start-up

Regulatory Submissions

Health Authority Interactions

Mentoring

Leadership

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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