We are the people who give possibilities purpose
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Responsibilities:(Primary Duties, Roles, and/or Authorities)
Under direct manager supervision, the Associate Clinical Project Manager will:
Manage thequality and compliance of assigned clinical project(s) ensuring that they meet the highest standards for scientific quality, integrity and ethics and are conductedin accordance withBD global clinical procedures, study protocols, GCP and all applicable regulations.
Plan and strategize with other business unit cross functional team members (R&D, Marketing, Quality, and other business partners) to define, implement and execute clinical strategies in support of businessobjectives.
Manage activities related to clinical strategy and study design, global applications, submissions, and product launches for assigned clinical project(s) as the clinical subject matter expert.
Develop Clinical Investigation Plans (CIPs), Informed Consent Forms (ICFs), Investigator’s Brochure’s (IBs), Clinical Study Management Plans, Study Process Risk Assessments, Regulatory Management Plans, Case Report Forms (CRFs), Clinical Product Management Plans, Clinical Investigation Reports (CIRs)and other essential clinical study documents.
Review and provide input on the development of other essential clinical study documents related to clinical data management, clinical statistics, site management & monitoring, clinical safety management, clinical productmanagementand clinical supplier management.
Manage complianceforrequired reporting, including but not limited to IDE annual reports, clinicaltrials.gov, and overseas notified bodies/competent authorities.
Provide critical thinking and leadership support for issue escalation related to clinical study activities. Interact with investigational sites, vendors, and other functional areas for issues, as needed. Proactivelyidentifyissues and create mitigation strategies in collaboration with Clinical Affairs leadership.
Conduct, attend, or support training and observational activities, as needed, for study teammembers.
Education and Experience:
Proficiencywith Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.)
Preferred Qualifications:
Physical Demands:(if applicable)
While performing the duties of this job, the employeeis regularly required tostand, walk, sit, use sight, and use hands to manipulate,handleor feel objects, tools, controls, and office equipment. The employeefrequentlyis required toverbally communicate with other associates. The employeeis occasionally required toreach with hands and arms and stoop, kneel or crouch.
Work Environment:(if applicable)
While performing the duties of this job, the employee may be in anopen cubicleenvironment. Candidatemust be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visithttps://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.
Required Skills
Optional Skills
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USA AZ - Tempe Headquarters
