Manager, Informed Consent, Informed Consent Management

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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 ( 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 a supportive culture, promoting global participation 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

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