Manager, Project Management & Ops. Delivery - Contract - Warren, NJ
Proclinical is seeking a Manager of Project Management & Operational Delivery to support diagnostic projects within drug development programs in the immuno-oncology and pharmaceutical space.
Primary Responsibilities:
The successful candidate will focus on project leadership, stakeholder collaboration, and operational excellence to ensure the successful delivery of diagnostic tools and strategies.
Skills & Requirements:
- Experience in biotech, pharmaceutical, or diagnostic industries, including CAP-CLIA laboratory settings.
- Familiarity with oncology clinical trials, companion diagnostics, and tumor tissue sample management.
- Certification in Project Management from an accredited institution.
- Proficiency in project management tools for timeline tracking and milestone identification.
- Strong collaboration, communication, and presentation skills.
- Knowledge of GxP, CAP-CLIA, IVDR, and applicable ISO regulations.
- Understanding of clinical laboratory practices, validation procedures, and regulatory requirements.
- Proficiency in business technology tools such as Microsoft Teams, Excel, and PowerPoint.
The Manager, Project Management & Ops. Delivery's responsibilities will be:
- Proactively manage a portfolio of diagnostic projects in collaboration with the Diagnostic Portfolio Manager.
- Build and maintain relationships with key stakeholders across clinical development units and other functions.
- Facilitate diagnostic assessments to align team efforts with clinical program needs.
- Drive the collection and organization of information to meet program deliverables.
- Develop and implement processes and tools to enhance quality, efficiency, and timely delivery of diagnostics.
- Partner with external diagnostic manufacturers, laboratories, and vendors to oversee project execution.
- Represent the Diagnostics team as a subject matter expert, addressing regulatory impacts and operational considerations.
- Coordinate cross-functional activities to ensure alignment with clinical study plans and timelines.
- Oversee project scope, budgets, contracts, risks, and dependencies.
- Review clinical protocols and trial deliverables to ensure accurate diagnostic representation.
- Manage laboratory specifications, assay development, and startup processes for clinical trials.
- Oversee diagnostic data delivery, including database lock plans and sample management.
- Actively participate in clinical study teams to align diagnostic planning with study objectives.
Compensation:
If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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