Associate Director Centralized Monitoring

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary

The Associate Director, Centralized Monitoring is a leadership, line management level role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Director, Centralized Monitoring (CMN) within the Global Data Management and Centralized Monitoring function of Global Development Operations (GDO).

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

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 the resources to pursue their goals, both at work and in their personal lives.

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, disability or protected veteran status.

Company info

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