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Senior Manager, Study Report Delivery
Department Title and Description
CDR&A is responsible for the ingestion, transformation, and delivery of clinical data to internal stakeholders, primarily to Biometrics and Data Sciences. CDR&A also acts as the study interface for delivery of reports and analytics to enable effective data review, trial status and risk identification. Engagement of clinical trial functions for reporting and analytic needs. Technical SMEs to ensure expert consultation on data modelling, transformation, and best-fit reporting tools.
Purpose/Objective the job
The PAL Senior Manager SRD, CDR&A is a key individual contributor responsible for managing multiple studies across various Therapeutic Areas. This role will serve as the primary point of contact for stakeholders and face Therapeutic Area leads across stakeholders, taking ownership of the entire report development and delivery process. This includes gathering reporting and analytics requirements, utilizing tools and programming languages such as SAS, elluminate Mapp, and Qlik to develop reports, and ensuring adherence to defined processes, timelines, and deliverable quality standards. The PAL Senior Manager will play a crucial role in driving efficient and effective reporting and analytics solutions for our organization.
Key Responsibilities and Major Duties
• Serve as the primary point of contact for multiple studies in different Therapeutic Areas
• Collaborate with clinical stakeholders to understand their reporting and analytics needs aligned with study protocols
• Translate requirements into comprehensive reporting development specifications, in collaboration with Report end users.
• Utilize existing standard reports whenever possible and to suggest solutions as needed for any new additional requirements.
• Act as a subject matter expert, should foster innovation to promote efficiency in daily operations. This includes consistently providing solutions to enhance the report development process, optimize the utilization of reporting tools, and offering training to colleagues and stakeholders as required.
• Adapt to departmental and organizational initiatives, including the implementation of new tools/programs or any changes, with an anticipation of future benefits. Provide constructive feedback and suggestions to improve and strengthen the department further.
• Execute strategic initiatives while managing complex situations, adapting to new tools and methodologies, and implementing best practices for critical activities such as migration and change management.
• Develop reports and analytics visualizations according to specified requirements, ensuring a "first time right" approach.
• Test developed reports, document results, and provide peer review support as needed.
• Adhere to documentation and process compliance, notifying management of any noncompliance.
• Knowledge on regulatory requirements such as ICH, FDA 21 CFR part 11 and GxP.
• Analyse clinical trial needs holistically to determine effective monitoring approaches and ensure patient safety.
• Negotiate with stakeholders and foster collaboration for efficient report delivery.
• Assess the mission critical trial deliverables requirements and prioritize them, accordingly, seeking assistance as necessary.
• Demonstrate technical expertise to develop solutions for complex reporting needs.
• Work cohesively with team members, embracing feedback and suggestions.
• Keeping up to date with new reporting tools, techniques, and industry trends to enhance skills and knowledge.
• Embrace feedback and suggestions, continuously working to enhance knowledge and professionalism in the work environment.
• Participate in departmental/organizational activities/initiatives at the site level to build contacts across the organization, fostering collaboration for the benefit of patients.
• Contribute to other sub-functions of CDR&A as needed to support business priorities.
• Flexible to work with global stakeholders across different time zones while ensuring business continuity as needed.
Experience Requirements
• BS computer science/Math's/Stats/Life Sciences, programming, data management, scientific or analytic discipline
• 8+ years' experience in the development of reporting and analytics in the Pharmaceutical Industry with a focus on clinical trials.
Key Competency Requirements
• Experience with various reporting and analytic tools like SAS, Qlik, SQL/PLSQL and added advantage, if experienced in eClinical tool elluminate Mapper.
• Hands on experience in SDLC (Software Development Life Cycle) process
• Strong understanding of relational databases and ETL concepts.
#HYDDD #LI-Hybrid
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 science(TM) , 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 adastaffingsupport@bms.com . Visit careers.bms.com/ 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.
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