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Bristol Myers Squibb Associate Director, Centralized Monitoring in Princeton, New Jersey

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.

Position Responsibilities

  • Provides leadership of CMN activities across multiple clinical development programs, overseeing a team of central monitoring professionals in planning, coordination, and timely delivery of information to support risk evaluation and mitigation, internal decision making, regulatory approval and market acceptance

  • Empowers and holds staff to high quality performance and delivery of the business

  • Managing the book of work. Assigning resources to studies and initiatives, monitoring workloads to avoid delays in delivery due to resource constraints. Forecasting future resource needs based on the book of work

  • Assignment of staff, providing support and guidance as needed, and working with peers to ensure consistent approaches in-

  • Gathering of risk review requirements from various sources, including ensuring adherence to defined standards and championing consistency across programs and therapeutic areas

  • User acceptance testing of CMN tools to ensure high quality deliverables and inspection readiness at all times

  • Implementation of the Centralized Monitoring Strategy Plan (CMSP), defining and documenting the risk review strategy for each clinical trial in collaboration with various BMS stakeholders (e.g. statistics, medical, safety, development, GDO, etc.)

  • Strong coordination of CMN activities across relevant functional groups to ensure cohesive support to clinical trial risk assessment, review, and reporting

  • Develop strong and productive working relationships with key stakeholders throughout GDMCM, GDO, and BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management

  • Ensuring adaptive management of a global team through the effective deployment of resources and streamlined processes, ensuring productivity targets, validity and quality of the data gathered in support of the evolving portfolio of BMS products

  • Effective coaching and mentoring of Central Monitors to ensure consistently high levels of performance and productivity in support of various clinical trial teams

  • Engage and energize employees through communication of goals, priorities and other business critical information as well as focus on employee value proposition, development and retention activities

  • Develop and promote a work place culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability

  • Provides ongoing feedback, coaching, and career development, including engagement and retention support to staff to maximize their potential

  • Thinks strategically about trial risk assessment and review approaches that will support Risk Based Quality Management (RBQM) and Centralized Monitoring

  • Drives strategic development and implementation of methods to quantify and visualize indicators of risk, including any applicable training material. Identifies and engages stakeholders as appropriate to assess gaps, challenges, and opportunities for support

  • Ensure effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing CMN activities on behalf of BMS

  • Represent the Company in interactions with key external partners as part of any committee or industry group relating to Risk Based or Centralized Monitoring

  • Leads development, embedding, growth and health of the necessary business processes to support risk mitigation and global monitoring processes that align with the risks of BMS programs and protocols

  • Provide user input on IT needs necessary to support all aspects of CMN

  • Contribute to the development and maintenance of metrics that inform the evaluation of central monitoring performance and effectiveness

  • Supporting clinical study report creation with input to the data quality assurance section

  • Contributing to the development and application of smart systems and optimal approaches to support the monitoring of sites and data to simplify and enhance user experience or lead to efficiencies in execution

  • Focusing on continuous improvement, defining and implementing the changes required to create an industry-leading RBQM and CMN capability as well as contributing to wider GDMCM and GDO initiatives

  • Ensure procedural documents are reflective of industry standards, easily followed, and regularly maintained

  • Accountable to resolve issues and proactively develop solutions, within CMN and across functions

Degree and Experience Requirements

  • Degree required in one of the following disciplines or related field (advanced degree preferred): Life Sciences; Analytics; Data Science; Statistics

  • Atleast7yearsofglobalclinicaltrialexpertiseandasuccessfultrackrecordofleadingthroughinfluence,workingacrosscomplex, globalorganizationalmatrices.lmmuno-Oncologytherapeuticexperienceishighlydesirable. At least 3 years of direct exposure to RBQM and/or CMN activities and methodologies is preferred. At least 2yearsinaleadership / supervisorycapacity is required.

Key Competency Requirements

  • Global clinical trial expertise and a successful track record of leading through influence and communication, working across complex, global organizational matrices, with a proven ability to engage, manage, develop and inspire a geographically diverse team

  • Immuno-Oncology therapeutic experience is highly desirable

  • Strong understanding of RBQM & CMN industry trends and emerging technologies supporting trial risk management. Broad intelligence of the RQBM / CMN environment across key regions and regulators, and anticipation of future trends and impact

  • Good knowledge of industry leading eCRF tools (e.g., Medidata Rave, Oracle, etc.)

  • Strong knowledge of regulatory guidelines, especially pertaining to trial risk management

  • Good understanding of Systems Development Lifecycle (SDLC) principles

  • Demonstrated partnership across various collaborative industry forums and CROs

  • Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality, etc.)

  • Solution oriented

  • Can think broadly regarding risk review strategies

  • Experience interacting with Informatics on large scale projects

  • Well-versed in analytical and conceptual capabilities

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Company: Bristol Myers Squibb

Req Number: R1541121

Updated: 2021-06-22 04:46:17.235 UTC

Location: Princeton,New Jersey

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.