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.