Bristol Myers Squibb
Pharmaceuticals
Manager,InformedConsent,InformedConsentManagement
Neural analysis suggests this role is
optimal for Manager candidates.
“Manager, Informed Consent, Informed Consent Management at Bristol Myers Squibb. Skills: Informed consent, Clinical trials, Regulatory compliance. Triage study language modifications. Review language modifications”
Industry & Context.
Identify and resolve complex issues; Critical thinking; Solve problems; Exercise good judgment
<5% domestic travel
What They're Looking For.
Must Have
Bachelor's degree scientific/technical, 5+ years pharma/clinical experience, Experience with informed consent documents, Understanding of GCP requirements
Nice to Have
Experience in clinical specimen management, Experience in biobanking/repositories, Experience in biomarker research, Experience in genetics research
What You'll Do.
Triage study language modifications
Review language modifications
Process language modifications
Engage with stakeholders
Track modification requests
Assign modification requests
Track ethic committee queries
Assign ethic committee queries
Track health authority queries
Assign health authority queries
Collaborate with cross-functional teams
Ensure patient safety
Ensure specimen compliance
Ensure data compliance
Provide subject matter expertise
Support BMS IC process
Identify consent issues
Resolve consent issues
Liaise with Country Operations
Ensure adherence to local laws
Guide teams on consent template
Solve complex problems
Exercise good judgment
Review consent documents
Interpret consent allowable uses
Interpret consent retention periods
Maintain adherence to collection
Maintain adherence to retention
Maintain adherence to utilization
Execute informed consent processes
Serve as point of contact
Negotiate consent language
How You'll Work.
Team & Collaboration
Cross-functional teams; Regional Country Operations
Communication Scope
Written communication; Verbal communication; Presentation skills; Oral communication
Process & Methodology
Manage multiple priorities, Manage complex projects
Full Job Description
**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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. Read more: [careers.bms.com/working-with-us](https://careers.bms.com/working-with-us). BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation. **Position Responsibilities:** * Central triage of all study, county, and site level language modifications. * Review and process language modifications and engage with relevant stakeholders who manage key concept language per BMS SOPs. Manage escalations key stakeholders, as appropriate. * Track and assign requests for language modifications, ethic committee or health authority queries related to IC or other supporting materials. * Collaborate with cross-functional teams across BMS to ensure both patient safety and quality, and specimen and data compliance. * Provide subject matter expertise related to informed consent and support the BMS IC process including during audits and ins
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