Manager, Project Management & Operational Delivery

ProclinicalWarren, USA

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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 :

60.00 - $70.00 Per Hour

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Project Manager • Warren, USA