Associate Director, Informed Consent Management
4 days ago
Bristol Myers Squibb is a global biopharmaceutical company that is transforming patients' lives through science. We are seeking an experienced Associate Director to join our Informed Consent Management team, reporting to the Director of Informed Consent Management. The successful candidate will be responsible for managing the end-to-end process for informed consent for BMS-sponsored clinical trials, including centralized triage, language modifications, and template management.
Key Responsibilities:
- Manage the informed consent process for BMS-sponsored clinical trials, ensuring compliance with regulatory requirements and company policies.
- Develop and maintain informed consent templates, processes, and technology to support implementation in clinical trials.
- Collaborate with cross-functional teams to ensure patient safety and quality, and specimen and data compliance.
- Provide subject matter expertise and oversight on the informed consent process in support of clinical operations, including during audits and inspections.
- Establish objectives, strategies, priorities, and plans to ensure appropriate governance, oversight, and compliance to the process.
Requirements:
- Bachelor's degree with a concentration in a scientific- or technical-related discipline. Master's degree preferred.
- At least 6-8 years in the pharmaceutical industry and 3-5 years of experience in clinical operations and/or Good Clinical Practice, with direct experience related to informed consent required.
- Proficient understanding of Good Clinical Practice (GCP) and Human Subject Research requirements.
- Thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of compliance issues related to patient rights and data privacy.
- Strong program and project management experience with proven track record of several years managing cross-functional programs and ability to manage multiple, simultaneous projects.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company that is transforming patients' lives through science. We are committed to improving the lives of patients with serious diseases, and we are seeking talented individuals to join our team. If you are passionate about making a difference in the lives of patients, we encourage you to apply for this exciting opportunity.
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