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BD (Becton, Dickinson and Company) Sr. Clinical Project Manager in Limerick, Ireland
Job Description Summary
The Senior Clinical Project Manager (Sr. CPM) will lead and oversee clinical performance evaluation studies for BD devices in Europe, focusing on the procurement of human bio-specimens for analytical and clinical studies. This role involves collaborating with cross-functional teams, including Medical and Scientific Affairs, Clinical Affairs, and Global Clinical Affairs, to manage and complete studies in compliance with regulations like Good Clinical Practices (GCP), IVDR, and GDPR. The Sr. CPM will guide the planning, execution, and closeout of complex clinical evaluations, from protocol development through study conduct. They will also work with investigators, site staff, Ethics Committees, Health Authorities, and Key Opinion Leaders to ensure the success of the clinical studies.
Key Responsibilities:
1. Managing complex clinical evaluations, preparing and reviewing essential study documents, and overseeing relationships with Contract Research Organizations (CROs), vendors, and clinical sites.
2. Managing budgets, timelines, and resources, ensuring studies are executed on schedule and within budget.
3. Identifying suitable clinical sites, managing training materials, ensuring the study trial master file is complete, and addressing risks.
4. Mentoring less experienced team members and providing regular communication with internal and external stakeholders to ensure the successful execution of clinical trials.
Education and Experience:
Advanced degree in relevant scientific discipline (PhD, PhD, MD), or master’s degree (Biological Sciences or Biomedical engineering focused on Biotechnology). Minimum of 6 years of relevant industry experience in product development or a combination of equivalent education and experience, preferably with in-vitro diagnostics.
Knowledge and Skills:
* Result and detail-oriented, self-motivated with ability to take risks, willing to learn, experience with literature research method and databases preferred.
* Working knowledge of MS Office, strong skills with MS Excel, EndNote, Pubmed, Medline and/or database development.
* Excellent verbal communication skills and ability to work effectively in a matrixial work environment is required.
* Extremely motivated and willingness to work in a fast-paced environment with interdisciplinary team(s).
Preferred Qualifications:
* Experience in clinical laboratory work.
* Previous experience with BD Biosciences systems and reagents highly desirable (BD FACSCanto, BD FACSLyric, BD FACSDuet, BD LWA/SPA or LSR Fortessa).
* Experience using flow cytometric analysis software (Diva, FlowJo, etc.).
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 Limerick - Castletroy
Additional Locations:
IRL BD and CO Dublin South, IRL Wexford - Enniscorthy
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