Associate Director, Clinical Data Management

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $173.2k - $209.9k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Bristol Myers Squibb

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1887

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Bristol Myers Squibb is a global biopharmaceutical company that is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Their areas of focus include cardiovascular health, cell therapy, immunology, and oncology. With a commitment to transforming patient outcomes through pioneering science, Bristol Myers Squibb partners with a worldwide network of researchers, healthcare providers, and other stakeholders. They aim to lead in innovation for patients while fostering diversity and inclusion within their workforce.

📋 Description

• Provide data management leadership, insight, and support to all internal and external projects and clinical trials. • May simultaneously function as lead Clinical Data Manger for multiple clinical trials. • Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards. • Manage and provide oversight of data management personnel and activities of CROs and vendors. • Ensure CRO adherence to project timelines, from study startup to study closeout, while maintaining high quality and integrity of deliverables. • Engage in cross-functional meetings, providing updates on project status, issues, and milestones. • Review data using listings and visualization tools for performance and quality reporting, conducting reviews within studies and across multiple studies for trend analysis. • Lead interactions with third-party vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study-specific data. • Proficient in clinical systems, including EDC, IVRS, CTMS, eTMF, and other clinical project management tools; ability to learn new systems as needed. • Contribute to SOP development and updates to meet regulatory compliance and operational needs. • 10% of travel required.

🎯 Requirements

• Bachelor’s degree • Minimum of 6 years of data management experience in pharmaceutical/biotech/CRO industry • Extensive hands-on experience in all aspects of data management. • Experience in the Oncology therapeutic area. • Proven ability to manage CRO relationships and oversee data management deliverables. • Strong knowledge and experience of EDC systems (Medidata RAVE or Veeva). • Solid knowledge of GCP, CDISC/CDASH data structures, ICH guidelines and FDA regulations. • Excellent verbal and written communication skills. • Strong analytical and problem-solving abilities. • Applies AI to improve team execution and decision-making.

🏖️ Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care. • Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). • Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. • Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.