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BD (Becton, Dickinson and Company) Clinical Study Manager in Baltimore, Maryland

Job Description Summary

Job Description

The Clinical Study Manager is responsible for clinical trial management and monitoring of multiple studies including the planning, implementation, oversight and completion of clinical trials conducted that are post market studies. The Clinical Study Manager will ensure that Investigator Sponsored Studies (ISS) and post market studies or research collaborations are initiated and executed as required. This role serves as the combined study manager and monitor of moderate to high complexity from study initiation, through study conduct and closeout in compliance with Good Clinical Practices, and all Global, National and Local Regulations as well as MA Governance of ISS studies. Collaborates with SA Clinical Project Lead to review business requests, and evaluate or develop early plans and concepts for optimal study execution.

Responsibilities

  • Develops and manages group of studies for an entire business unit or large development program; oversees/leads study-specific study management and monitoring activities

  • Prepares, reviews or supplies as needed study-related or essential study start-up documents as they relate to the assigned clinical trials e.g., Clinical Protocols, Informed Consent forms, Investigator Brochures, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters) for BD sponsored post market studies.

  • Ensures study supplies and product training is initiated and maintained as needed.

  • Serves as study monitor over the study conduct and milestone progress.

  • Addresses issues that may arise during execution of clinical studies.

  • May manage relationships with site personnel and other study related vendors, including CRO’s.

  • Defines, tracks and reports schedule attributes such as durations, interdependencies, milestones, budgets, critical path and other key deliverables for assigned studies.

  • Adapts work package deliverables based on study scale and complexity.

  • Proactively identifies and manages risks and issues (including a log, mitigations, and contingencies) to ensure cost effective timely delivery of the project including escalation if needed

  • Plans and maintains high quality standards in order to meet compliance requirements.

  • Leads or contributes to continuous improvementactivities/initiatives.

  • Ability to travel approximately 30% of the time, US and Internationally.

Requirements:

  • BS Degree in Medical Technology, Microbiology, Biology, Chemistry, Immunology or equivalent

  • A minimum of 2+ years of Clinical Microbiology experience.

  • Project management experience desirable using MS Project and/or recent proven success within a BD product development core/extended team.

  • Knowledge of clinical trial concepts and practices

  • Strong client and vendor relationship management skills.

  • Ability to work effectively, independently with multi-level teams, manage multiple projects and work in a fast paced and changing environment.

  • Demonstrated and effective interpersonal, communications and negotiation skills for a wide variety of audiences.

  • Ability to work effectively in a virtual environment.

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.

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Primary Work LocationUSA MD - Sparks - 7 Loveton Circle

Additional Locations

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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