Bristol Myers Squibb

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. 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. Supporting People with Disabilities Bachelor's degree with a scientific- or technical-related discipline. Minimum 5+ years' experience in pharma/clinical drug development/scientific discipline 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) and adaptable to available online tools and databases.