Study Start-up Specialist
Il y a 7 mois
**Working with Us**
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
**Outline of Key responsibilities**:
- Responsible for activities related to Clinical Trial Study Start Up and ongoing study document management across Northern Europe Cluster (UK, Ireland, Belgium, Netherlands).
- Manage multiple country, study and site level deliverables during start-up and maintenance both within BMS and external business partners and vendors, when required.
- Plan and develop strategy for start-up activities to ensure successful recruitment and delivery to trial milestones.
- 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).
- Collaborate with other internal roles in country feasibility and site selection.
- Collaborate 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 protocol-specific country Informed Consent Form (ICF).
- Customise site ICFs.
- Review and approval of Clinical Trial Package (CTP) documentation.
- Ensure that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management.
- Support the collection and distribution of documents from / to sites including obtaining insurance certificates.
**Required experience**:
3 or more years of industry related experience including handling of trial start-up activities
**Degree Requirements**:
Bachelor's degree required preferably within life sciences or equivalent.
**Key competency requirement**:
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.
**Languages requirement**:
Good verbal and written communication skills, both in English and local language such as Dutch/French.
LI-Hybrid
**Uniquely Interesting Work, Life-changing Careers**
**On-site Protocol**
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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