Senior Manager, External Clinical Trial Data Integration - Berkeley Heights, NJ, United States - Bristol-Myers Squibb

Bristol-Myers Squibb Berkeley Heights, NJ, United States

4 weeks ago

Description

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, External Data Integration contributes directly to the success of the BMS R&D pipeline is responsible for the effective integration of external clinical trial data.

This role reports to the Associate Director, External Data Acquisition within GDM&CM and is a full-time, office-based position.

Position Responsibilities:
Configuring systems used to acquire and integrate external clinical trial data to meet study data requirements.

External data may include vendor generated lab results, IVRS data, CRO datasets, and other clinical trial data coming to BMS via data file transfer in accordance with industry standards and regulatory requirements.

Overseeing the loading and integration of external clinical trial data using secure and controlled systems.
Troubleshooting and resolving issues with external data loading and integration, working with other stakeholders as needed.
Serving as the external data integration subject matter expert and providing technical data acquisition/integration support for clinical trial execution.
Contributing to the validation and testing of external data acquisition/loading systems.
Understanding and documenting the flow of external clinical data through various systems.
Identifying and resolving issues which may negatively impact study deliverables, 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.

Contributing to the development and application of smart systems and optimal approaches to support the loading and integration of external data.

Actively participating and/or leading in continuous improvement activities, defining, and implementing the changes required to create industry-leading capabilities.
Supporting preparations and follow-up actions related to Health Authority inspections and internal audits.
Liaising with and reviewing work delivered by partners (e.g. Function Service Providers, outsourcing partners, etc.) performing external data acquisition/integration 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.

Qualification Requirements:

Bachelor's degree required with computer programming or technical data integration disciplines preferredAt least 5 years of global clinical trial expertise with a focus on external clinical data acquisition and integration.

At least 5 years' experience with technical and programming skills required for supporting external data integration and debugging system issues.

Solid understanding of the drug development process and clinical trial start-up/execution. Proven expertise in external data acquisition and integration technologies.

Strong knowledge of industry leading external data integration tools and well versed in industry trends and emerging technologies supporting data integration.

Strong knowledge of GCP/ICH guidelines.
Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
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 access our complete Equal Employment Opportunity statement.

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

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