Senior Manager, EDC Database Development (R1539102-en-us-1)
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.
The Senior Manager, EDC Database Development contributes directly to the success of the BMS R&D pipeline is responsible for the effective development of study level EDC databases.
This role reports to the Associate Director, EDC Database Development within GDM&CM and is a full-time, office-based position.
This is a full-time, office-based position located in Central New Jersey, USA.
- Building, maintaining and deploying study databases to collect clinical trial data, including configuring study database internal module connections and external system integrations. Being responsible for initial study database development and changes required after initial deployment. Taking responsibility for more complex studies in the portfolio which may require additional expertise.
- Contributing to the development of appropriate timelines for development and deployment of study databases.
- Providing EDC technical expertise to Data Management and to the clinical study team members to support study decisions.
- Managing work assignments to ensure timely delivery.
- Identifying and resolving issues which may negatively impact delivery of work, using collaborative strategies to reach resolution. Escalating issues to leadership appropriately.
- Following procedural documents and participating in reviewing and updating of documents to make sure they are reflective of industry standards and regulatory requirements and include optimal processes.
- Training and/or mentoring newer EDC Database Development team members on key activities and processes.
- Contributing to the development and application of smart systems and optimal approaches to support the collection of data.
- Actively participating in and/or leading continuous improvement activities, defining and implementing the changes required to create an industry-leading electronic data capture capability.
- Supporting preparations and follow-up actions related to Health Authority inspections and internal audits.
- Liaising with and reviewing work delivered by external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing activities on behalf of BMS.
- Developing strong and productive working relationships with key stakeholders throughout GDMCM, GDO, and BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.
- Representing the Company in interactions with key external partners as part of any committee or industry group relating to global library develompent.
Experience and expertise required:
- Bachelor’s degree required with an advanced degree preferred. At least 5 years of relevant industry experience.
- Solid understanding of the drug development process with proven expertise in clinical trial start-up/execution and EDC database development.
- Strong knowledge of industry leading EDC tools (e.g. Medidata Rave, Oracle/Inform, etc.) and well versed in industry trends and emerging technologies supporting data collection.
- Strong knowledge of clinical study design.
- Strong knowledge of GCP/ICH guidelines.
- Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
- Understanding of database and dictionary structures (e.g. MedDRA, WHODrug).
- Experience with CDISC standards including CDASH and SDTM is desirable.
- Demonstrated partnership across various collaborative forums.
- Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.).
- Demonstrated ability to self-start, be solution-oriented, collaborate effectively with stakeholders, drive activities to completion, and be accountable for results.
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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