Senior Unblinded Study Specialist (R1557854-en-us)
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:
The Unblinded Study Specialist (USS) will provide protocol level support when unblinded IP is used in a blinded study. The responsibilities of this role are targeted to supporting the protection and maintenance of the blind. The role is structured to optimize issue resolution, to avoid accidental unblinding events and mitigate regulatory risks. The role will liaise with blinded and unblinded staff to minimize potential errors.
Key Responsibilities and Major Duties:
- Ensure study specific Unblinded Clinical Trial Monitor (UCTMo) training is developed and delivered, working with blinded Clinical Trial Monitors and Clinical Trial Managers.
- Develops study specific quick reference tools for UCTMo field utilization.
- Provide single point of contact for routine support of UCTMos, unblinded site staff and local unblinded Leads; this includes system issues, patient dosing issues and other questions.
- Track and record potential/actual unblinding events with Unblinded Clinical Trial Monitors, Randomization Coordinator and Unblinded Operations Lead.
- Work with Clinical Supply Operations and Unblinded Clinical Trial Monitors regarding any supply issues, Use Date Extension Notices and Additional Labeling Forms.
- Consult with Unblinded Operations Lead regarding safety and dosing issues. If necessary consult with Medical Monitor in a blinded fashion regarding safety & dosing issues.
- Review and complete Unblinded Site Monitoring Visit Reports. Advises Unblinded Clinical Trial Monitors, in collaboration with the Unblinded Operations Lead, on site protocol deviation documentation and follow up.
- Assist in creating, editing and tracking of Unblinded Data Correction Forms.
- Assists in Risk Based Monitoring review and analysis.
- Review Interactive Response System Reports on quarterly basis, resolves issues with Unblinded Clinical Trial Monitors and Unblinded Pharmacists as needed.
- Participate in team meetings to escalate issues and discuss lessons learned.
- Ensures proper study document flow and sequestration prior to study unblinding and/or end of study to ensure maintenance of blind.
- Facilitates drug transfer, return and/or destruction at Clinical Completion Event (CCE) or site closure.
- Assist Randomization Manager and Global Biometric Sciences in Investigational Product reconciliation at database lock.
- Support the audit response team for findings related to blinded Investigational Product.
- Engage with line management to assist in the resolution of more complex issues
- Acts as a subject matter expert for the role and relevant processes
- Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations.
(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)
- Stakeholders within the RCO Clusters
- Stakeholders within Global Development Operations
- R&D Quality
- Bachelors degree required preferably within life sciences or equivalent.
- At least 5 years of monitoring experience. Demonstrate leadership skill, mentor and coach capability
- Experience as an unblinded site monitor preferred
- Knowledge of ICH/GCP Guidelines and applicable local laws and regulations (Health Authorities) which govern clinical trials.
- Knowledge and understanding of clinical research processes, regulations and methodology.
- Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management.
- Organization and time management skills. Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations.
- Good verbal and written communication skills (both in English and local language).
- Microsoft Suite
- Clinical Trial Management Systems(CTMS)
- Electronic Data Capture Systems (eDC)
- Electronic Trial Master File (eTMF)
- Travel Required (nature and frequency) Minimal
- Overnight Absences Required (per typical month) ~0-1
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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