Job Description Summary

　　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.

　　Why join us?

　　A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

　　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.

　　Become a maker of possible with us!

　　At the Enniscorthy facility, we manufacture angioplasty devices for the treatment of Peripheral & Coronary artery disease. In the last years, thanks to our in-house R&D team, we have diversified the offering. We design, develop and manufacture innovative and exciting minimally invasive medical devices associated with peripheral artery disease, diabetes, surgical procedures, and oncology. Our teams bring to the market novel solutions, as well as keep developing internal equipment allowing us to be flexible. For you, this means the opportunity to make an impact on a global scale, both on-site and collaborating with people from around the world.

　　Job Description

　　About the role

　　The successful Clinical Project Manager (CPM) 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.

　　Main responsibilities will include:

　　Under the direct supervision of the Director, Clinical Program Manager and/or Sr. Clinical Project Manager, the CPM will:

　　Oversee the planning and execution of clinical studies, including clinical study timeline development, to ensure that deliverables are completed on time and within budgetDevelop clinical study protocols, informed consent forms (ICFs), case report forms (CRFs), and other essential clinical study documentsDevelop clinical study reports for submission to regulatory authoritiesDevelop and track the clinical study budget, including invoice review/approval and monthly accrualsOversee and review deliverables produced by study team members to ensure quality and complianceManage external vendors to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of workEnsure that studies comply with BD policies, standards and procedures, FDA regulations, ISO standards, Good Clinical Practice (GCP) and other applicable regulationsDemonstrate understanding of BD's general business functions, products, and procedures and serve on cross-functional project teams as a clinical subject matter expertDevelop and implement standardized processes and operating procedures for conducting clinical researchSupervise department personnel as neededCreate and maintain clinical study documents as part of the trial master file (TMF)Interact with investigational sites, vendors, key opinion leaders (KOLs) and consultantsConduct on-site clinical monitoring activities as neededLead and actively participate in various cross functional team meetingsAbility to effectively prioritize tasks and responsibilities and ensure project milestones are metResponsible for timely creation and maintenance of clinical study registration and updates

　　About you

　　BSc/MSc/PhD in LifeSciences, Biomedical Engineering, Medicine or similar backgroundFive (5) or more years of experience in Clinical ResearchThree (3) or more years of experience managing clinical research studiesStrong working knowledge of Good Clinical Practice (GCP), FDA and ISO regulations, and current industry practices related to the conduct of clinical studiesAbility to work independently, manage multiple projects and personnel in a fast-paced environment, and effectively navigate obstaclesExcellent communication skills (oral and written)Strong computer skills, Proficiency with Microsoft Office Suite applicationsStrong interpersonal and organizational skillsAbility to travel up to 40%

　　Click on apply if this sounds like you!

　　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.

　　To learn more about BD visit: https://bd.com/careers

　　Primary Work Location

　　IRL Wexford - Enniscorthy

　　Additional Locations

　　Work Shift