Sr. Clinical Project Manager

6 days ago

Cork, Cork, Ireland BD Full time

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.
  • Managing budgets, timelines, and resources, ensuring studies are executed on schedule and within budget.
  • Identifying suitable clinical sites, managing training materials, ensuring the study trial master file is complete, and addressing risks.
  • Mentoring less experienced team members and providing regular communication with internal and external stakeholders to ensure the successful execution of clinical trials.

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:

  • Representing Medical and Scientific Affairs in the product development team and supporting the Core Team activities.
  • Managing more complex clinical evaluations or combinations of protocols.
  • Establishing and updating the clinical development plan(s) and/or medical affairs plan.
  • Preparing and/or reviewing study-related or essential study start-up documents as they relate to the assigned clinical trials.
  • Managing relationships with CROs, other vendors and sites/PIs.
  • Identifying required resources and developing the budget for the clinical evaluation.
  • Establishing strategies with the clinical team for site identification, qualification and selection.
  • Managing resources and ensuring availability and designates equipment to perform required testing at selected sites.
  • Defining, tracking and reporting schedule attributes such as durations, interdependencies, milestones, critical path and other key deliverables.
  • Adapting work package deliverables based on study scale and complexity.
  • Creating aggressive but achievable budget, resource estimates, forecasts and timelines.
  • Working cross-functionally with Core Team and GCA for site contracts, stats and data management.
  • Overseeing quality and content of the training materials for site and trains the site staff as required.
  • Drafting and submitting for review and approval the clinical study report(s).
  • Ensuring the study trial master file is complete prior to Good Clinical Practice quality audit.
  • Managing and preparing for and responding to real and potential risks that could compromise the metrics and progress of the study.
  • Communicating effectively with internal and external partners and stakeholders.
  • Working with outside parties, such as laboratory professionals, CROs, FDA, Notified Body or Health Authority.
  • Mentoring associates with less experience.

About You

Education and Experience:

  • Advanced degree in relevant scientific discipline (PhD, PharmD, 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.
  • Previous experience 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.
  • 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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