TempeRecruiter Since 2001
the smart solution for Tempe jobs

Clinical Affairs Project Manager (Remote Opportunity)

Company: Becton Dickinson & Company
Location: Tempe
Posted on: April 5, 2021

Job Description:

Job Description SummaryJob DescriptionThe 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 requiredBecton, 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-PROPrimary Work LocationUSA AZ - Tempe HeadquartersAdditional LocationsWork Shift

Keywords: Becton Dickinson & Company, Tempe , Clinical Affairs Project Manager (Remote Opportunity), Executive , Tempe, Arizona

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Assistant Salon Manager - Foothills Safeway Center
Description: Assistant Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to support other stylists Then let's talk Maybe you're a stylist who wants more responsibility,
Company: Great Clips
Location: Tolleson
Posted on: 04/17/2021

Assistant Salon Manager - Stonehenge Center
Description: Assistant Salon Manager br br Got shears and a winning attitude Have a yearning to earn and a desire to support other stylists Then let's talk Maybe you're a stylist who wants more responsibility, (more...)
Company: Great Clips
Location: Phoenix
Posted on: 04/17/2021

Assistant Salon Manager - Val Vista Square
Description: Assistant Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to support other stylists Then let's talk Maybe you're a stylist who wants more responsibility,
Company: Great Clips
Location: Phoenix
Posted on: 04/17/2021


Director, Order to Cash Process (Client Billing)
Description: PRIMARY PURPOSE: br br The Director, Order to Cash Process is responsible for the direction and results of the Billing and Accounts Receivable functions. Responsible for the ongoing planning and design (more...)
Company: Vitalant
Location: Phoenix
Posted on: 04/17/2021

Assistant Salon Manager - Prasada Marketplace
Description: Assistant Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to support other stylists Then let's talk Maybe you're a stylist who wants more responsibility,
Company: Great Clips
Location: Surprise
Posted on: 04/17/2021

Audit Manager - Lending
Description: Purpose of JobWe are seeking a talented Audit Manager - Lending for our San Antonio, TX, Phoenix, AZ, or Plano, TX. Relocation assistance is available for this position. Remote work is NOT available. (more...)
Company: USAA
Location: El Mirage
Posted on: 04/17/2021

Licensed Health Insurance Agent - Cutting Edge Lead Management Platform
Description: Assurance, a Prudential company, is hiring Under 65 Health Insurance Sales Agents in your city. If you're already a Licensed Insurance Agent have a Residential Insurance License, we want to hear from (more...)
Company: ASSURANCE Independent Agents
Location: Camp Verde
Posted on: 04/17/2021

Assistant Salon Manager - Prasada Marketplace
Description: Assistant Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to support other stylists Then let's talk Maybe you're a stylist who wants more responsibility,
Company: Great Clips
Location: Youngtown
Posted on: 04/17/2021

Salon Manager - Mulberry Marketplace
Description: Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to hire and support other stylists Then let's talk Maybe you're a stylist who wants more responsibility,
Company: Great Clips
Location: Paradise Valley
Posted on: 04/17/2021

Salon Manager - Lake Pleasant Towne Center
Description: Salon ManagerGot shears and a winning attitude Have a yearning to earn and a desire to hire and support other stylists Then let's talk Maybe you're a stylist who wants more responsibility,
Company: Great Clips
Location: Fountain Hills
Posted on: 04/17/2021

Log In or Create An Account

Get the latest Arizona jobs by following @recnetAZ on Twitter!

Tempe RSS job feeds