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.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: .
Position Summary
- Responsible for activities related to study start up(SSU) and ongoing study document management
- Act as point of contact for local study teams and external stakeholders
- Independently manages multiple country, study and site level deliverables during start-up and maintenance both within internal and external business partners and vendors, when required.
- Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trialmilestones.
- Ensure Investigator Sites are eligible 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/IRB 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 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
- Complete 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 analyze the SSU process, looking for innovative ways to introduce efficiencies in order to speed-up start-up timelines, whilst maintaining quality.
- Ensures hub is kept up to date on changes in country specific requirements.
- 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.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through scienceTM , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.
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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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