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 include managing complex clinical evaluations, preparing and reviewing essential study documents, and overseeing relationships with Contract Research Organizations (CROs), vendors, and clinical sites. The Sr. CPM will manage budgets, timelines, and resources, ensuring studies are executed on schedule and within budget. They will also be responsible for identifying suitable clinical sites, managing training materials, ensuring the study trial master file is complete, and addressing risks. Additionally, the Sr. CPM will mentor less experienced team members and provide regular communication with internal and external stakeholders to ensure the successful execution of clinical trials

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.

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!

Our vision for Biosciences at BD

BD Biosciences (BDB) is a leading provider of high-quality flow cytometry and single-cell genomics solutions, scientific research and clinical laboratories. Here, we are leading the way by developing the best technologies that have the ability to look closer at the details of cells and diseases.

About the role

The Senior Clinical Project Manager will collaborate with the core team associates, extended core team associates, and Global Clinical Affairs associates, providing Medical and Scientific Affairs support within the various phases of product development and performance evaluation of the BD devices. The Sr. Clinical Project Manager will be responsible for planning, implementing, overseeing, managing, and completing performance evaluation studies involving human bio-specimen procurement for analytical and clinical studies conducted within Europe. This role serves as the project lead for moderate to high complexity studies from protocol development through study conduct and closeout in compliance with Good Clinical Practices and all Global, National and Local Regulations (i.e., IVDR, GDPR, etc.). Reports to and collaborates with Clinical Execution Director or designated supervisor to review business requests and evaluate or develop plans and concepts for optimal study execution of the BD sponsored performance evaluation of new devices and post-market activities within Europe. The Sr. CPM represents Medical and Scientific Affairs and BD Biosciences in the interactions with investigators, site staff, submissions to Ethic Committee(s), country Health Authority official and Key Opinion Leaders.

Main responsibilities will include:

• Represents Medical and Scientific Affairs in the product development team, also supports the Core Team activities (document and design review and approval, informed consent, if applicable for specimen collection for analytical testing by third parties (i.e., BD Qualified Specimen Suppliers).

• Manages more complex clinical evaluations or combinations of protocols.

• Establishes and updates the clinical development plan(s) and/or medical affairs plan.

• Prepares and/or reviews study-related or essential study start-up documents as they relate to the assigned clinical trials (e.g., Clinical Protocols, Informed Consent forms, Investigator Brochures, Monitoring Plan, Laboratory Manual, Clinical Site Procedures, Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).

• Manages relationships with CROs, other vendors and sites/PIs.

• Identifies required resources and develops the budget for the clinical evaluation.

• Establishes strategies with clinical team for site identification, qualification and selection to determine suitability of specimen sources, types and flow at the laboratory and historical data.

• Manages resources, also ensures availability and designates equipment to perform required testing at selected sites.

• Defines, tracks and reports schedule attributes such as durations, interdependencies, milestones, critical path and other key deliverables including efficiency and effectiveness of plans and staff.

• Adapts work package deliverables based on study scale and complexity. Remains on schedule, ensuring the timely completion of each phase deliverables.

• Creates aggressive but achievable budget, resource estimates, forecasts and timelines. Monitors the study’s budget, to ensure the work is staying within approved parameters.

• Works cross-functionally with Core Team and GCA for site contracts, stats and data management to determine the data collection as well as recording the data.

• Oversees quality and content of the training materials for site and trains the site staff as required.

• Drafts and submits for review and approval the clinical study report(s).

• Ensures the study trial master file is complete prior to Good Clinical Practice quality audit.

• Manages and prepares for and responds to real and potential risks that could compromise the metrics and progress of the study.

• Communicates effectively with internal and external partners and stakeholders.

• Works with outside parties, such as laboratory professionals, CRO’s, FDA, Notified Body or Health Authority.

• Mentors associate with less experience

About you

Education and Experience:

• Advanced degree in relevant scientific discipline (PhD, PhamD, 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, preferable with in-vitro diagnostics.

• Previous experience in in Hematology/ Hematopathology highly desirable.

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

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Primary Work Location

IRL Limerick - Castletroy

Additional Locations

IRL BD and CO Dublin South, IRL Wexford - Enniscorthy

Work Shift