Associate Director, Data Management - San Diego, United States - Bristol Myers Squibb

Bristol Myers Squibb San Diego, United States

3 weeks ago

OTHER

Description

Working with Us
Challenging. 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 rich in diversity.

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:
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RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA.

Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving the survival of people with cancer by harnessing the power of targeted radioisotopes.

RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS.

RayzeBio is developing innovative drugs against targets of solid tumors.

The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier-stage testing for patients with small cell lung cancer (SCLC) and breast cancer.

Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

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 manage relationships with external partners and collaborate across cross-functional teams to ensure data deliverables and expectations are met.

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 Manager 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 collecting, transmitting, and transferring 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.

Knowledge and Skills:

Proven ability to manage CRO relationships and oversee data management deliverables.
Strong knowledge and experience of EDC systems (Medidata RAVE preferred).
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.

Qualifications:

Bachelor's degree in Life Science, mathematics, or health-related fields preferred.
A minimum of 6 years of data management experience in the pharmaceutical/biotech/CRO industry, with extensive hands-on experience in all aspects of data management.
Experience in the Oncology therapeutic area is preferred.

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.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through scienceTM , every BMS employee plays an integral role in work that goes far beyond ordinary.

Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs.

The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.

For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.

For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.

Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.

If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to .

Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.

As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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Associate Director, Data Management - San Diego, United States - Bristol Myers Squibb

Description

Asset Data Manager

Data Project Manager

Manager Data Science

Manager, Clinical Data Management