Job Description Summary
As Clinical Project Manager, you will be responsible for supporting BD's business objectives by overseeing the development, implementation and execution of one or more assigned clinical projects from concept through study completion. The Clinical Project Manager will also oversee quality and compliance for assigned clinical projects ensuring that projects are completed on time, within budget, that they meet the highest standards for scientific quality, integrity and ethics, and are conducted in accordance with BD global clinical procedures, study protocols, GCP and all applicable regulations. The Clinical Project Manager will also provide guidance and oversight for the day-to-day activities of study team members on assigned projects. Candidates must be able to work on-site in our Tempe, AZ office location.
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Job Description
We are the makers of possible
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.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
Primary Responsibilities:
- Manage the quality and compliance of assigned clinical project(s) ensuring that they meet the highest standards for scientific quality, integrity and ethics and are conducted in accordance with BD 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 business objectives.
- Demonstrate a comprehensive understanding of the therapeutic areas and competitive landscapes for assigned clinical project(s).
- Oversee the planning and execution of assigned clinical projects to ensure that deliverables are completed on time and within budget. Develop and manage metric reporting tools as needed to track project timelines and deliverables. Provide regular and ad hoc reporting of metrics to Clinical Affairs leadership.
- 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 product management and clinical supplier management.
- Develop and manage clinical study budgets and monthly financial reviews, including invoice review/approval and accruals for assigned clinical project(s).
- Manage compliance for required reporting, including but not limited to IDE annual reports, clinicaltrials.gov, and overseas notified bodies/competent authorities.
- Perform study and/or site-level audits of the Trial Master File (TMF) to ensure that study files are current, accurate, complete and audit-ready.
- Oversee study and site-level management of the Clinical Trial Management System (CTMS) to ensure that study and site details are current, accurate and complete.
- Interact with and/or oversee interactions with investigational sites, vendors, key opinion leaders (KOLs) and consultants.
- Manage external contractors/suppliers for assigned clinical project(s) to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work.
- Coach and ensure successful and effective relationships between study teams and investigational site personnel.
- 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. Proactively identify issues and create mitigation strategies in collaboration with Clinical Affairs leadership.
- Provide support for internal or external audits/inspections and ensure resolution of audit/inspection findings related to assigned clinical projects.
- Conduct Site Management & Monitoring, Clinical Product Management and Clinical Field support activities/visits, as needed.
- Conduct, attend, or support training and observational activities, as needed, for study team members.
About You:
- Minimum bachelor's Degree (BS/BA) in life sciences or equivalent combination of training and experience (MA/MS preferred)
- Minimum 5+ years of experience in clinical research (medical device, pharmaceutical and/or biotechnology)
- Minimum 3+ years of experience in managing clinical projects
- Strong working knowledge of domestic and international clinical research regulations and guidelines, Good Clinical Practice (GCP) and current industry practices related to the conduct of clinical studies
- Proficiency with Microsoft Suite tools (Outlook, Word, Excel, PowerPoint, OneNote, To-Do, SharePoint, etc.)
- Strong knowledge of clinical study processes and systems (eTMF, CTMS and CDMS)
- Strong interpersonal and communication (oral and written) skills
- Strong organizational skills, attention to detail, critical thinking and analytical skills
- Able to manage and delegate multiple tasks and prioritize importance of tasks/projects
- Ability to understand and interpret technical, scientific, and clinical information as it applies to product approval activities
- Ability to lead teams to translate issues into actions, make decisions and influence outcomes
- Ability to travel up to 40% (or more during peak times)
Preferred Qualifications:
- Prior experience with clinical studies related to peripheral vascular diseases, end-stage kidney disease and/or oncology
- Experience with medical device studies (strongly preferred)
- Prior experience with site management & monitoring
- Prior experience with Veeva Vault Clinical Suite (CTMS, CDMS and eTMF)
- Professional certification through one or more relevant associations (e.g., ACRP, SOCRA, etc.)
Physical Demands:
While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
Work Environment:
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must 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.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
For certain 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, testing for COVID-19 may be available and/or required. 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 encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
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 health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
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.
Primary Work Location
USA AZ - Tempe Headquarters
Additional Locations
Work Shift