Sr. Specialist, Study Start-Up

Bristol-Myers Squibb

Full-time - Mid Level

Chemical Manufacturing

About the position

At Bristol Myers Squibb, we are committed to transforming patients' lives through science, and this role is pivotal in achieving that mission. As a Study Start-up Senior Specialist, you will independently manage multiple country, study, and site-level deliverables during the start-up and maintenance phases of clinical trials. This includes collaborating with both internal teams and external business partners to ensure that all trial milestones are met efficiently and effectively. You will be responsible for planning and developing strategies for start-up activities, which are crucial for successful recruitment and timely delivery of trial objectives. Your role will involve preparing investigator sites to conduct clinical trials by reviewing and approving essential clinical trial and regulatory documents. You will support local regulatory teams in preparing submissions for Health Authorities, ensuring that all necessary documentation is submitted and followed up on until approval. This includes substantial amendments and any other documentation requiring Health Authority submission. Additionally, you will prepare and perform submissions for Ethics Committees, ensuring that all required documents are submitted and approved in a timely manner. Collaboration is key in this position, as you will work closely with internal study teams, external site staff, and country ethics committees to align tasks and priorities with defined study timelines. You will also be responsible for reviewing and approving Clinical Trial Package (CTP) documentation and ensuring that the electronic Trial Master File (eTMF) contains all relevant regulatory documents for site activation and ongoing study management. Your expertise will be essential in supporting Health Authority inspections and audit preparations, as well as in identifying innovative ways to enhance the start-up process and improve efficiency while maintaining high-quality standards. In this senior-level role, you will serve as a Subject Matter Expert (SME) for key investigational sites, documenting and maintaining relevant information about site structures, start-up processes, and key contacts. You will represent Bristol Myers Squibb in local working groups and meetings, proactively addressing local requirements and questions from Health Authorities and Ethics Committees. Your ability to analyze the start-up process and introduce efficiencies will be critical in speeding up timelines and ensuring successful trial outcomes.

Responsibilities

• Independently manage multiple country, study, and site level deliverables during start-up and maintenance.
• Plan and develop 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.
• Prepare and perform submissions for Ethics Committees including follow up until approval.
• Collaborate with other internal roles in country feasibility and site selection.
• Collaborate directly with BMS internal study teams, external site staff, and country ethics committees/IRB to ensure tasks and priorities are aligned to the defined study timelines.
• Review and approve Clinical Trial Package (CTP) documentation.
• Update national registries as applicable.
• 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.
• Support Health Authority inspection and pre-inspection activities.
• Support audit preparation & Corrective Action / Preventative Action preparation for local related issues.
• Serve as an SME for key investigational sites and maintain relevant information on the site's structure and processes.
• Represent BMS in local working groups around start-up processes in the country.
• Proactively work with stakeholders to prevent questions from Health Authorities based on observed past questions.
• Analyze the SSU process for innovative efficiencies to speed up start-up timelines.

Requirements

• Bachelor's degree required, preferably within life sciences or equivalent.
• 3 or more years of industry-related experience including handling of trial start-up activities.
• 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 with the ability to manage multiple competing priorities.
• Ability for critical thinking and risk analysis.
• Good verbal and written communication skills.
• Proficiency in Microsoft Suite, Clinical Trial Management Systems (CTMS), Electronic Trial Master File (eTMF), and document exchange portals.

Benefits

• Competitive salary and benefits package
• Opportunities for professional development and career growth
• Flexible work environment
• Diversity and inclusion initiatives
• Health and wellness programs