job title: clinical trial associate(bristomyers squibb)

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:

• Bachelor's 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.