At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Purpose/Objective of the job
- Responsible for activities related to study start up and ongoing study document management
- Act as point of contact for local study teams and external stakeholders
Key Responsibilities and Major Duties
- 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
Senior Level Expectations:
- 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.
Key Stakeholders/Contacts –
Protocol Manager (PTM), Clinical Trial Managers, Clinical Trial Monitors, Clinical Trial Associates (CTA), Site Relationship Managers, Site Contract Leads, Vendor Operations Managers, Regional Clinical Compliance Leads, Line Managers(LM), Head of Clinical Operations , local Regulatory, local Medical Affairs and Clinical Supply team members
Principal Investigator, Sub-Investigators, Study Coordinators, Research Nurses, Research Managers, Data Managers, Pharmacists, IRB Personnel, Regulatory agencies (as applicable), Vendors
BMS Job Profile
Study Start-up Specialist (D04)
List of minimum requirements
Bachelors or Masters Degree within life sciences or equivalent
Experience – Responsibility and minimum number of years
- Study Start-up Specialists - 3 or more years of industry related experience including handling of trial start-up activities
- 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
Competencies – knowledge, skills, abilities, other:
- 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).
Software that must be used independently and without assistance (e.g., Microsoft Suite):
- Microsoft Suite
- Clinical Trial Management Systems (CTMS)
- Electronic Trial Master File (eTMF)
- Document exchange portals
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.