Associate Director, EDC Database Development (R1553399-en-us-3)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
- Authoring database development procedural documents (SOPs, work instructions, job aids) and coordinating reviews/approvals. Ensuring procedural documents are reflective of industry standards and regulatory requirements, include optimal processes and are regularly maintained.
- Managing database development trackers, metrics, and key performance indicators for the function to ensure timely delivery, appropriate visibility, and proactive identification/resolution of issues and trends.
- Developing and maintaining database development templates and tools which support the function.
- Developing and conducting training and/or mentoring team members on key activities and processes.
- Ensuring consistency and adherence to BMS standards within the department as a whole.
- Holding accountability to resolve complex issues, leveraging technical/functional expertise to proactively develop solutions. Using clear communications and collaborative strategies to drive to resolution and remove barriers to execution.
- Leading CAPA management activities, including root cause analysis and development of appropriate actions to address the root cause. Ensuring timely closure of CAPA actions.
- Leading initiatives with broad, cross-functional impact (including strategic process and technology improvements), influencing direction and driving to completion.
- Representing the function for Health Authority inspections and internal audits. Ensuring preparations and follow-up actions are completed effectively.
- Ensuring effective quality oversight of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing activities on behalf of BMS to ensure high quality and timely delivery of clinical databases.
- Developing strong and productive working relationships with key stakeholders throughout GDM&CM, GDO, and BMS to drive results and remove barriers to execution.
- Representing BMS in interactions with key external partners as part of any committee or industry group.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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