Manager, Informed Consent, Informed Consent Management

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.

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 inspections as needed.

• Identify and resolve complex consent issues.

• Liaise with Regional Country Operations to ensure adherence to local laws/regulations/requirements.

• Guide BMS and CRO teams on use of informed consent template materials.

• Use critical thinking to solve problems and exercise good judgment.

• A subset of team members hired into the Manager IC role may also:
  review consent documents and interpret consent allowable uses and retention periods to maintain adherence to the collection, retention, and utilization of biospecimens and data in line with the informed consent signed by the subject.

• execute informed consent processes for clinical trials pertaining to use of specimens and data and act as subject matter expert in patient informed consent and regulatory topics around biospecimens.

• Serve as the point of contact for study-related inquiries from HAs/IRBs/ECs regarding biospecimen and biomarker objectives and negotiate related consent language.

• Travel expectations are minimal (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.

Candidate Rights

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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1603157 : Manager, Informed Consent, Informed Consent Management