Manager, Clinical Database Programming - Bear Mountain - job 1491909

Date: 12/04/2021

City: Bear Mountain, New York

Employment type: Full-time


Job Description Summary


Job Description


Be part of something bigger!


BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.


Job Description Summary:


The Manager, Clinical Database Programming is responsible for providing performance feedback and defining goals and objectives for direct reports as well as coaching and mentoring Clinical Database Programmers (CDP) for career development. He / she will provide leadership and direction to database programming staff. This is a working manager position and may be assigned as the lead CDP to clinical trials or other projects based on resource constraints. The Manager will ensure the quality and timeliness of all deliverables produced by the CDP team. The Manager will contribute to initiatives that examine data management processes and evaluate new technologies. The Manager may serve as a subject matter expert (SME) and guide the CDP team and Clinical Data Managers (CDM) with new designs and updates in the study conduct phase, and will troubleshoot complicated technical issues as required for staff regarding specific database issues. He / She will drive process improvement initiatives to completion and foster knowledge sharing and communication of best practices across all levels of Global Clinical Development.


Essential Job Functions:

  • Provide leadership, coaching, and management to assigned staff.


  • Responsible for providing performance feedback and defining goals and objectives for direct reports as well as coaching and mentoring for career development.


  • Provides input into resourcing assigned studies.


  • Identify gaps in current process, analyze and propose solutions.


  • Work with business unit personnel to ensure GCD is delivering high quality and timely data management services necessary to achieve their business goals


  • Contributes to initiatives aimed at acquiring new technologies.


  • Contributes to change control activities and validation efforts of the Clinical Data Management System (CDMS).


  • Develops database design specifications/definitions in consultation with data management, statistics and programming.


  • Designs and creates clinical databases to enable data review and validation of the study data by Data Managers, and a comprehensive and efficient analysis by Statistics and SAS Programming.


  • Programs and tests database configurations (edit checks, derivations, form/field dynamics, etc.).


  • Programs and tests reports using SQL/SAS to identify inconsistencies and support data review efforts.


  • Performs pre-processing and loading of non-CRF data files.


  • Contributes to solutions for routine technical problems and liaises with IT as appropriate to resolve issues.


  • Identify and implement solutions to data management issues and concerns that arise during the conduct of the study.


  • Identifies and understands the need for standardization and takes initiative to help improve departmental efficiency.


  • Establishes and maintains productive working relationships with all other functional areas that contribute to the execution of clinical studies.


  • Maintains knowledge of current regulations and technologies related to the CDP function.


  • Demonstrates project management skills including the ability to manage CDP aspects for outsourced studies.


  • Demonstrates an understanding of data structures, database design constraints and needs of SAS Programmers.


  • Authors and/or contributes to Departmental SOPs, Business Guidance and/or Standards/Templates to define best practice and promote consistency.


  • Maintains all required study documentation.


Required Qualifications:


  • Advanced proficiency in one or more leading EDC systems.


  • Advanced level SQL scripting.


  • Advanced level understanding of relational databases.


  • Knowledge of CDISC/CDASH.


  • Experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission.


  • Ability to work independently with minimal supervision and manage multiple deliverables concurrently.


  • Ability to ensure clinical database programming work is completed in a consistent manner and validated according to department practices.


  • Excellent interpersonal skills, strong written and verbal communication skills.


  • Working knowledge of clinical development.


  • Working understanding of clinical trial principles and technical implications.


  • Ability to interact effectively within and across team environment.


  • Promotes knowledge sharing in the group.


  • Ability to travel up to 10% of the time.


Additional Desirable Qualifications:


  • Basic knowledge of SAS preferred.


Education and/or Experience:


  • BA / BS computer science/information technology or life sciences from a 4-year accredited university.


  • Minimum 6 years clinical database programming experience preferred in the device / pharmaceutical / CRO industry.


  • Minimum 2 years direct people management experience, or an equivalent of indirect people management/mentoring and demonstrated leadership capabilities.


  • An equivalent combination of education, industry related experience, and performance may be considered.


For many roles
at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, weekly testing for COVID-19 may be available instead of vaccination. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.



Why join us?


A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

PDN


Primary Work Location


USA NJ - Franklin Lakes


Additional Locations


Work Shift





How to apply:

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