Job Description:
Job Description Summary
The Clinical Project Manager (CPM) independently manages all aspects of moderate to complex clinical performance studies conducted by BD Biosciences in compliance with Good Clinical Practices (GCP), and applicable regulations. The CPM leads the planning and execution of IVD clinical studies to ensure that results are completed on time and within budget. This role will also provide or assist in providing Site Management and Monitoring support for studies.
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.
Position Summary:
The successful Clinical Project Manager (PM) will participate in cross-functional project teams to plan and execute successful clinical studies, from concept through study completion, in support of corporate objectives. Additionally, the PM ensures that projects are completed on time, within budget, and in compliance with all regulatory requirements, Good Clinical Practice, & industry standards. The PM also provides oversight of the day-to-day activities of study team members and conducts personnel development and line management as needed.
Essential / Key Job Responsibilities (including supervisory and/or fiscal):
- Oversee the planning and execution of clinical studies, including clinical study timeline development, to ensure that deliverables are completed on time and within budget
- Develop clinical study protocols, informed consent forms (ICFs), case report forms (CRFs), and other essential clinical study documents
- Develop clinical study reports for submission to regulatory authorities
- Develop and track the clinical study budget, including invoice review/approval and monthly accruals
- Oversee and review deliverables produced by study team members to ensure quality and compliance
- Manage external vendors to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work
- Ensure that studies comply with BD policies, standards and procedures, FDA regulations, ISO standards, Good Clinical Practice (GCP), and other applicable regulations
- Demonstrate understanding of BD's general business functions, products, and procedures and serve on cross-functional project teams as a clinical subject matter expert
- Develop and implement standardized processes and operating procedures for conducting clinical research
- Supervise department personnel as needed
- Create and maintain clinical study documents as part of the trial master file (TMF)
- Interact with investigational sites, vendors, key opinion leaders (KOLs) and consultants
- Conduct on-site clinical monitoring activities as needed
- Lead and actively participate in various cross functional team meetings
- Ability to effectively prioritize tasks and responsibilities and ensure project milestones are met or exceeded
- Responsible for timely creation and maintenance of clinical study registration updates (ct.gov or global registrations for clinical studies conducted outside of the United States)
Required Qualifications:
- Five (5) or more years of experience in Clinical Research
- Three (3) or more years of experience managing clinical research studies
- Experience with Flow Cytometry is required.
- Strong working knowledge of Good Clinical Practice (GCP), FDA and ISO regulations, and current industry practices related to the conduct of clinical studies
- Ability to work independently, manage multiple projects and personnel in a fast-paced environment, and effectively navigate obstacles
- Excellent communication skills (oral and written)
- Strong computer skills
- Proficiency with Microsoft Office Suite applications
- Strong interpersonal and organizational skills
- Ability to travel up to 30%
Preferred Qualifications:
- Three (3) or more years of experience managing medical device studies
- Previous experience managing or mentoring personnel
- Previous site monitoring and/or CRA experience
Education and/or Experience:
- BA/BS (MA/MS preferred) in health science field or equivalent combination of training and experience
Primary Work Location and Additional Considerations:
- USA CA - Milpitas
- We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor Visas' at this time.
- We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to provide Relocation assistance at this time.
- We encourage Candidates near our BD Location of: CA - Milpitas to apply for this Hybrid role. Remote may be considered for the right candidates.
- This is a Hybrid role that requires you to be at your assigned worksite 3 days out of the week and up to 2 days from home. Local policies may apply. BD may change your work arrangement based on business needs .
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.
#earlycareer
Primary Work Location
USA CA - Milpitas 155
Additional Locations
Work Shift
At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You .
Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.
Salary Range Information
$126,600.00 - $208,900.00 USD Annual
More jobs in Milpitas, California
|
Becton Dickinson NA |
|
Becton Dickinson NA |
|
Eurofins |