Sr. Manager, Interactive Response Technology (IRT)

Location
Redwood City, CA
Posted
May 15, 2022
Ref
R1557722
Required Education
Bachelors Degree
Position Type
Full time

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 Summary

This position is required for the delivery of technology and services to enable the enrollment/randomization of patients into BMS clinical trials and to ensure clinical trial material availability.

Position Responsibilities

  • Lead successful execution and on time delivery of Interactive Response Technology (IRT) and support integrations with other clinical systems (e.g., Depots, Central Lab, and EDC), such that the resultant IRTs are fit-for-purpose as defined by protocol and study operational parameters with special emphasis on adherence to BMS standards and quality principles.
  • Lead IRT projects as a strategic partner and single point of accountability to partner lines for IRT protocol assessments, requirements elicitation, system deployments, and resupply.
  • Work independently and assume decision making responsibilities on assigned projects. Collaborate with the IRT Leadership Team where necessary to ensure BMS standards and/or for requests by study teams that are not within these standards or best practice are addressed.
  • Bring issues of concern or system failure to the immediate attention of the IRT Leadership Team.
  • Maintain vendor performance quality events in ADI log.
  • Lead and support IRT improvement initiatives and manages improvement projects that impact daily operations to improve efficiency.
  • Lead and support key department and enterprise level initiatives as the IRT representative and SME.
  • Lead and support the development and implementation of Standard Operation Procedures (SOP) and processes.
  • Responsible for generation an oversight of patient and container randomization schedules, ensuring parameters reflect the protocol and drug supply requirements. Distribute patient randomization and container schedules as appropriate to Clinical Supply Operations and IRT vendors.
  • Participate in IRT vendor relationships and oversight to ensure delivery of IRT systems and seamless services; as well as, foster a collaborative relationship.
  • Consult and ensure on time delivery of user acceptance testing of IRT systems consistent with BMS SOPs and procedures. This includes fostering collaboration and best practices with the IT QA organization.
  • Ensure systems and associated documentation are compliant with all Regulatory requirements, including cGMP, 21 CFR Part 11, ICH E6 (R2) as well as in accordance BMS SOPs and processes.
  • Ensure effective system access and functionality across all countries and all user locations
  • Ensure on time development of IRT data transfers with vendors and/or third-party vendors.
  • Act as a mentor to new hires by assisting with training on department processes and procedures.
  • During IRT Maintenance act as the primary contact for assigned studies for the cross-functional study team and vendor. Additionally, provide timely response to all randomization/IRT issues (including data integrations and delivery) that arise during IRT lifecycle and ensure they are resolved.
  • Support all unblinding activities.
  • Ensure eTMF compliance at the study level in accordance with group and BMS guidance.
  • Participate in the IRT subject matter expert (SME) program
  • Engage and support study and CSMT project teams as deemed necessary.
  • Ensure delivery of data to BMS departments and third-party vendors consistent with BMS SOPs and forms.
  • Additional tasks within scope of expertise and experience as assigned by the supervisor in pursuit of BMS goals.

Experience Requirements

  • Bachelor’s Degree
  • Minimum of 8 years ( 5 years IRT) work experience preferably in a health sciences or related IRT industry (pharmaceutical, hospital-based, laboratory, etc.)
  • Demonstrated analytical skills and a working knowledge of Microsoft Office including SharePoint

Key Competency Requirements

  • Clinical Research experience
  • Working knowledge of IRT
  • Working knowledge of Clinical Trial Management Systems
  • Working knowledge of clinical supplies
  • Able to think outside of the box, have excellent communication and analytical skills to successfully deliver optimal IRT solutions across a diverse and dynamic portfolio
  • Understand the nature of clinical data and concepts of IRT study design and configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards
  • Exposure to working in a GMP / GCP environment and with regulatory audit teams
  • Possess excellent English language written and verbal communication, interpersonal, collaboration and business partnership capabilities required
  • Comfortable working with a global team, partners and customers in a change agile environment
  • MS Project, MS Visio, or any other requirements visualization and analysis tools

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.

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 if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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