Manager, Informed Consent, Informed Consent Management in Hyderabad, India

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 rich in diversity. 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 (

Degree Requirements

Bachelor’s degree with a scientific- or technical-related discipline.

Experience Requirements

Minimum 5+ years’ experience in pharma/clinical drug development/scientific discipline

Key Competency Requirements

The incumbent should have proficient skills in each of the following areas:

• Experience in the biopharma industry in clinical trial operations, with direct experience working with informed consent documents required.

• Experience in clinical specimen management, biobanking/biorepositories, biomarker and/or genetics research is also desirable.

• Strong written and verbal communication, presentation and organizational skills required.

• Ability to operate in a complex matrix organization.

• Understanding of Good Clinical Practice (GCP) requirements.

• Excellent interpersonal, organizational, and oral and written communication skills.

• Ability to effectively handle multiple, simultaneous, and complex tasks and projects and establish priorities.

• Ability to manage multiple priorities and complex projects in a dynamic environment.

• Skilled in multi-tasking in a fast-paced environment.

• Proficiency with Microsoft Teams, Office 365 Applications, Labmatrix or consent tracking platform, clinical trial systems (CTMS, eTMF) a nd adaptable to available online tools and databases.

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/ (https://careers.bms.com/eeo-accessibility) 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/

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

Company: Bristol-Myers Squibb

Req Number: R1585783

Updated: 2024-09-27 01:55:14.249 UTC

Location: Hyderabad-IN

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.