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The Informed Consent (IC) Management function at BMS sits within Global Development Operations (GDO) and is responsible for managing the end-to-end process for IC for BMS-sponsored clinical trials. This includes a centralized triage function for informed consent negotiations with global clinical trial sites, IRBs/ECs, and health authorities, as well as management of templates, processes, and technology to support implementation of informed consent in our trials. This team is evolving the BMS approach to informed consent by leveraging internal and external best practices and exploring technologies.
The Associate Director (AD), Informed Consent Management role reports to the Director of Informed Consent Management. The AD will be responsible for informed consent activities and will also serve as the Global Process Lead for IC at BMS. The AD will be responsible for triaging and addressing questions and requests for IC language changes supporting our global clinical trials and will be responsible for IC codification to document permissions and restrictions associated with specimens and data. The AD will also assist in the development of processes, procedures, templates, and technology to facilitate informed consent as well as lead process optimization to align with the QMS document hierarchy.
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. Manage escalations key stakeholders, as appropriate.
- 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.
REQUIRED QUALIFICATIONS AND EXPERIENCE:
- 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.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in 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.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
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