Associate Director, Informed Consent Management

2 weeks ago

Princeton, New Jersey, United States Bristol-Myers Squibb Company Full time
Transforming Patients' Lives through Science

Bristol-Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking an experienced Associate Director to join our Informed Consent Management team.

About the Role

The Associate Director, Informed Consent Management will be responsible for managing the end-to-end process for informed consent for BMS-sponsored clinical trials. This includes centralized triage, language modifications, and management of templates, processes, and technology to support implementation of informed consent in our trials.

Key Responsibilities
  • Central triage of all study, county, and site level language modifications
  • Review and process language modifications and engage with relevant stakeholders per BMS SOPs
  • Track and assign requests for language modifications, ethics committee or health authority queries related to IC or other supporting materials
  • Identify and resolve complex consent issues and mentor junior team members
  • Drive collaboration with cross-functional teams across BMS to ensure both patient safety and quality, and specimen and data compliance
  • Independently liaise with Regional Country Operations to ensure adherence to local laws/regulations/requirements
  • Use critical thinking to solve problems and exercise good judgment
  • Serve as the Global Process Lead for Informed Consent
  • Drive the development and continuous improvement of policies, procedures, processes, and support technology solutions to aid in the execution of a compliant process
  • Develop and maintain, in collaboration with stakeholders and SMEs, BMS Global IC templates for use in BMS-sponsored clinical trials
  • Ensure appropriate governance and oversight is in place and effective for the IC templates
  • Collaborate with cross-functional teams in and outside of GDO in order to ensure both patient safety and quality are the foundations of the IC processes
  • Provide subject matter expertise and oversight on the IC process in support of clinical operations, including during audits and inspections
  • Establish objectives, strategies, priorities and plans to ensure appropriate governance, oversight and compliance to the process
  • Collaborate with Outsourcing Management team to develop appropriate process and communications with Clinical Research Organizations and other external partners to ensure compliance with applicable requirements for the IC
  • Working with management and Global Quality to foster a cross functional mindset of Quality Excellence, Quality by Design, Inspection Readiness at all times, and Growth Mindset
  • Partnering with the Training, Process and Continuous Improvement team to ensure appropriate training is current
  • Keep abreast of the changing regulatory landscape and engage externally as appropriate with industry consortia
Requirements
  • Bachelor's degree with a concentration in a scientific- or technical-related discipline. Master's degree preferred
  • At least 6-8 years in the pharmaceutical industry and 3-5 years of experience in clinical operations and/or Good Clinical Practice, with direct experience related to informed consent required
  • Proficient understanding of Good Clinical Practice (GCP) and Human Subject Research requirements
  • Thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of compliance issues related to patient rights and data privacy
  • Strong program and project management experience with proven track record of several years managing cross-functional programs and ability to manage multiple, simultaneous projects
  • Demonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing global environment with shifting priorities
  • Experience with partner management
  • Experience in process improvement methodology and Lean Sigma is a plus with a mindset for Simplification
  • Knowledge of IT systems used to support clinical trial processes and the authoring of clinical trial related documentation is desirable
  • Good understanding of the drug development process and clinical operations, experience in risk management, audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions (CAPA) process
  • Experience in matrix management is required at all levels in the organization
  • Ability to engage and inspire others at all levels in the organization
  • Excellent communication skills with a proven ability to effectively engage and manage key internal stakeholders at all levels (in various functions and geographies) as well as external stakeholders (including Health Authorities)
  • Excellent presentation and negotiation skills with the ability to resolve conflict in a timely and constructive manner
  • Ability to manage multiple projects simultaneously to ensure timely, on budget execution of tasks. Attention to detail with excellent planning, time management and organizational skills

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.

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