Cra Ⅰ

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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. 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: careers.bms.com/working-with-us . Act as point of contact for Sites. Implements the local country and site feasibility process, including proposal and validation of country study targets, as endorsed by country leadership. Plans, develops and executes timelines and activities for start-up in collaboration with the local study team, Global Trial Acceleration Centre (GTAC) and other relevant stakeholders 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. Manage the end-to-end process for executing Clinical Trial Agreements (CTAgs) with investigator sites. Prepares contract documents from templates and modify to reflect unique aspects of the particular study, including the CTAg financial appendix Negotiates financial and legal aspects of CTAg and Master Service Agreements with sites, Institutions or vendor personnel 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 Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management Update national registries as applicable Prepare of materials for Site Initiation Visits. Conduct support Investigator Site Assessment Visits (ISAs) and Site Initiation Visits (SIVs). Conduct site qualification, initiation, routine monitoring and close-out visits， including post-close out across all trial phases in accordance with the Site Monitoring Plan, ensuring adherence to protocol, BMS Standard Operating Procedures (SOPs) and ICH GCP Perform submission to Site Ethics Committees and Site GCP Institution, including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission). Coordinate the Site Ethics Committees and Site GCP Institution responses with study teams. Collect and distribute of documents to and from sites including obtaining insurance certificates. - Maintain the ethical and scientific integrity of clinical trials by verifying data within electronic systems and paper records (as applicable) to ensure the accessibility, completeness and accuracy of data submitted by study sites. - Monitor site adherence to ICH GCP and local regulations, including compliance with the principles of ALCOA to maintain data integrity and reliability. Where required, provide training and support to site staff to uphold these standards and ensure patient safety. Cultivate and sustain effective relationships with internal cross-functional teams and external partners, including vendors, clinical sites, and key stakeholders. Serve as the organization's representative for clinical trials at the site level. Motivate and influence sites to meet study objectives, including enrolment and retention goals. - Communicate effectively, adapting to meet the needs of different stakeholders, utilizing the most appropriate communication style and method. - Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner. - Assess potential Investigators and their sites to ensure sufficient resources and capabilities to conduct clinical trials. May identify new potential Investigators and/or sites through ongoing collaborations with internal and external stakeholders during the site feasibility and selection process. - Demonstrate understanding and proficiency working with targeted, centralized, remote and risk-based monitoring approaches. - Identify, assess, and prioritize risks at the site and study level and support sites in mitigating issues, including implementing mitigation strategies based on risk indicators. - Utilize strong analytical skills to evaluate site data and operational metrics, including ability to adjust monitoring strategies based on data

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