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Bristol-Myers Squibb in Russia is seeking to recruit a permanent Senior Start up Specialist.
Bristol-Myers Squibb is a global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases.
Key Duties and Responsibilities
Independently manages multiple country, 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 issues
Serves as an SME for key investigational sites. Documents and maintains relevant information on the site’s structure, start-up processes, key contacts, etc (i.e., Site Playbook) for sharing with internal team members.
Represents BMS in local (e.g. pharma association or HA driven) working groups around start up processes in the country
Represents BMS in meetings discussing local requirements / repetitive questions from local Health Authority and Ethics Committees
Proactively works with stakeholders (e.g. document template owners, GRS, CMC, CSO) to prevent questions from HA based on observed past questions. Constantly analyse the SSU process, looking for innovative ways to introduce efficiencies in order to speed-up start-up timelines, whilst maintaining quality.
Qualifications And Experience Required
Bachelors or Master degree required. Field of study within life sciences or equivalent
5 years or more of industry related experience that includes significant experience in coordination of trial start-up activities and support to Health Authority / Ethic Committee submissions
Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
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).
Microsoft Suite
Clinical Trial Management Systems (CTMS)
Electronic Trial Master File (eTMF)
Document exchange portals
What’s Important To Us
Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
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