Manager, Informed Consent, Informed Consent Management

Career Areas Career Stories Join Talent Community Candidate Login English English Italiano Español Français Português Norsk Deutsch 日本語 Bahasa melayu 中文 (简体) 中文 (繁體) 한국어 ภาษาไทย Nederlands Polski Yкраїнська Hrvatski Ελληνικά Magyar čeština Türkçe Pусский Haitian עברית Brazilian Português Dansk Suomi Svenska Français (Canada) Português (Portugal) Careers Home Life at BMS Career Areas Student Opportunities Events How We Recruit Career Stories Search this site Join Talent Community Candidate Login English English Italiano Español Français Português Norsk Deutsch 日本語 Bahasa melayu 中文 (简体) 中文 (繁體) 한국어 ภาษาไทย Nederlands Polski Yкраїнська Hrvatski Ελληνικά Magyar čeština Türkçe Pусский Haitian עברית Brazilian Português Dansk Suomi Svenska Français (Canada) Português (Portugal) Single PositionView All JobsManager, Informed Consent, Informed Consent ManagementHyderabad - TS - INApply NowFind out how well you match with this jobUpload your resumeJob descriptionLife at BMSWorking with UsChallenging. 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 RequirementsBachelor's degree with a scientific- or technical-related discipline....