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Sr. Manager, Regulatory Affairs

Company: BD (Becton, Dickinson and Company)
Location: San Jose
Posted on: May 3, 2021

Job Description:

Job Description Summary

Clinical Project Manager

Job Description

The successful Clinical Project Manager (CPM) will participate on multi-disciplinary project teams to plan and execute successful clinical studies in support of Business Unit / Corporate objectives. The CPM will demonstrate proficiency in all areas of clinical study development and execution with an ability to build and direct effective multi-disciplinary project teams. The CPM may also provide line management to other Clinical Affairs personnel as needed.

Responsibilities:

  • Participate on cross functional core project team to ensure clinical deliverables are aligned with Business Unit and/or Corporate objectives;

  • Oversee the planning and execution of clinical studies to ensure that deliverables are completed on time and within budget;

  • Support regulatory submission activities globally where clinical study data is needed to show product safety and efficacy;

  • Develop and manage study related documents and materials such as study protocol, investigational plans, case report forms, study manuals, monitoring plan, informed consents, investigator brochure, websites, recruitment materials and other study related tools;

  • Develop and manage overall study budgets; negotiation of budgets with clinical sites, vendors, and consultants

  • Coordinate the development, drafting, and submission of clinical reports, clinical study data, and Summary of Safety and Effectiveness Data. Support and provide data reviews of abstracts, manuscripts, presentations, Instructions for Use, and other materials that include study data;

  • Support product launch activities as needed;

  • Select and manage external vendors(including but not limited to CROs, core labs, and physician consultants) to ensure that deliverables are completed on time, within budget, and are consistent with the scope of work;

  • Develop an understanding of competitive landscapes for assigned products and therapeutic areas;

  • Demonstrate understanding of Business Unit general business functions, products, and procedures;

  • Conduct on-site clinical monitoring/quality activities as needed;

  • Interact with investigative sites, vendors, and other functional areas to ensure successful execution of a clinical trial;

  • Ensure that internal and external clinical study teams fulfill their responsibilities in accordance with corporate standards, regulations, and good clinical practice;

  • Oversee and review work product of project team members to ensure quality and compliance, providing training or mentoring as needed;

  • Oversee appropriate reporting and documentation of adverse events and protocol deviations per investigational plan requirements;

  • Plan investigator and coordinator meetings and prepare and present meeting materials;

  • Oversee development and management of clinical database;

  • Develop and implement standardized processes and operating procedures for conducting clinical research;

  • Provide direct line management for Clinical Affairs personnel as needed.

Required Qualifications:

  • BA/BS (MA/MS preferred) in health science field or equivalent combination of training and experience

  • 4+ years of experience in the Clinical Research Industry;

  • 2+ years of experience in managing clinical research studies;

  • Previous site monitoring experience is preferred;

  • Previous experience managing personnel is preferred;

  • 3 + years experience with peripheral vascular devices is preferred;

  • Strong working knowledge of Good Clinical Practices (GCP), FDA regulations, and current industry practices related to the conduct of clinical trials;

  • Excellent communication skills (oral and written)

  • Strong computer skills;

  • Proficiency with MS Windows based applications;

  • Strong interpersonal and organizational skills;

  • Ability to work independently, manage multiple projects and personnel in a fast paced environment, and effectively navigate obstacles;

  • Travel of 20-40% domestic and international required

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.

#LI-PRO

Primary Work Location

USA AZ - Tempe Headquarters

Additional Locations

Work Shift

Keywords: BD (Becton, Dickinson and Company), San Jose , Sr. Manager, Regulatory Affairs, Other , San Jose, California

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