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75 Bristol-Myers Squibb Jobs
Clinical Trial Associate
Bristol-Myers Squibb
posted 8hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Responsible for activities related to study start up and ongoing study document management
- Act as point of contact for local study teams and external stakeholder
- Independently manages study and site level deliverables during start-up and maintenance both within BMS and external business partners and vendors, when required.
- Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trial milestones
- Prepare Investigator Sites to conduct clinical trials 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.
- Prepare and perform submissions for Ethics Committees including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission).
- Collaborates with other internal roles in country feasibility and site selection.
- Collaborates directly with the BMS internal study teams, external site staff, country ethics committees/IRB to ensure tasks and priorities are aligned to the defined study timelines
- 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
- Update national registries as applicable
- Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management
- When applicable, conduct drug/IMP label review translation
- Serves as expert on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and legal
- May support the collection and distribution of documents from / to sites including obtaining insurance certificates
- May support Health Authority inspection and pre-inspection activities
- May support audit preparation Corrective Action / Preventative Action preparation for local related issue
Minimum Qualification and Experience:
- Bachelors degree required preferably within life sciences or equivalent
- Thorough understanding of GCP, ICH Guidelines and Country regulatory environment
- In depth knowledge and understanding of clinical research processes, regulations and methodology
- Demonstrated organizational and planning skills and independent decision-making ability
- Strong organization and time management skills and ability to effectively manage multiple competing priorities
- Ability of critical thinking and risk analysis.
- Good verbal and written communication skills (both in English and local language)
- Minimum of 2 year industry related experience.
Employment Type: Full Time, Permanent
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Flexible timing
Monday to Friday
No travel
Day Shift
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