Associate Director, Clinical Data Management
$173.22k - $209.9kBristol-Myers Squibb
At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you'll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact-on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio:
RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals Associate Director, Clinical Data Management Summary The Associate Director, Clinical Data Management, will play a crucial role in our data management efforts, ensuring the accuracy, consistency, and integrity of clinical data. This position involves leading and overseeing all aspects of data management, from planning and coordination to execution and quality control. The successful candidate will be responsible for managing relationships with external partners and collaborating across cross-functional teams to ensure data deliverables and expectations are met. Job Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned.- 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.
- 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.
- Bachelor's degree in Life Science, mathematics, or health-related fields
- 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
Work Environment The noise level in the work environment is usually moderate. 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. Compensation Overview: Remote - United States - US: $173,217 - $209,899 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- 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.
- 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
$157.36k - $236.04k
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