• Bristol-Myers Squibb
  • Bergenfield , NJ
  • Non-Executive Management
  • Full-Time
  • 30 W Clinton Ave

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The Senior Manager, Clinical Data Acquisition & Standards (External Data Setup Manager) is a role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Associate Director, Clinical Data Acquisition & Standards (External Data Setup) within the Global Data Management and Centralized Monitoring (GDMCM) function of Global Clinical Operations (GCO). This is a full-time, office-based position located in Central New Jersey, USA or Belgium. Responsibilities Include Driving the data collection strategy for vendor generated test results, championing consistency across programs and therapeutic areas. Serving as the subject matter expert for the setup of external vendors at the study level, managing the completion of study start up, amendment and post final changes. Creating data transfer specifications, ensuring vendor data are compatible with the clinical database and SDTM requirements to support data integration, analysis and reporting. Working with Clinical Data Management to develop appropriate content and timelines for development and deployment of study databases. Identifying and resolving issues which may negatively impact study deliverables. Escalating issues to leadership as needed. Following procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and easily followed. Contributing to the development and application of smart systems and optimal approaches to support the collection of data. Actively participating in continuous improvement activities, defining and implementing the changes required to create an industry-leading electronic data capture capability. Liaising with and reviewing work delivered by external partners (e.g. laboratories, eCOA providers, technology providers, etc.) performing testing or data collection services on behalf of BMS. Developing strong and productive working relationships with key stakeholders throughout GDMCM, GCO, and BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management. Representing the Company in interactions with key external partners as part of any committee or industry group. Experience and Expertise Required Bachelor s degree required with scientific or data integration disciplines preferred. At least 5 years of relevant industry experience with Data Management experience preferred. Global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices. Immuno-Oncology therapeutic experience is highly desirable. Good understanding of the drug development process with proven expertise in clinical trial execution and data acquisition in a global arena. Strong knowledge of industry leading eCRF tools (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection. Strong knowledge of GCP/ICH guidelines. Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks. Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.). Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team. By fostering a culture of inclusion, we empower this 21st century workforce to achieve our company's mission of helping patients to prevail over serious diseases. Explore Job Opportunities A clear purpose. An inclusive culture. The chance to work at the top of your field. These are a few of the reasons Bristol-Myers Squibb is the right choice for your next career move. Are you ready for a career where you make a profound difference? We invite you to visit us at one of our events to learn more. Bristol-Myers Squibb endeavors to make this website accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact ...@bms.com. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. The Physician Payment Sunshine Act (Sunshine Act) requires Bristol-Myers Squibb to report any transfers of value, including payments made to reimburse interview-related expenses, for candidates who are US-licensed physicians. U.S. licensed Physicians covered by the Sunshine Act include Doctors of Medicine, Osteopathy, Dentistry, Dental Surgery, Podiatry, Optometry and Chiropractic Medicine who are licensed to practice medicine in the U.S. This information will be reported to the Centers for Medicare and Medicaid Services (CMS) on an annual basis and CMS shall post submitted data on its public database. For more information, click here. Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. For our EEO Policy Statement, please click here. If you'd like more information on your EEO rights under the law, please click here: EEO is the LAW and Supplemental Information.

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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