Rick Malinowski

About Rick Malinowski

20+ years experience in managing Global Clinical Studies within the pharmaceutical industry.• Advanced knowledge of clinical trial operations and the logistical and operational components necessary for the planning, implementation, and conduct of all clinical trials including inventory management, supply logistics and distribution.• Strategic planning, resource allocation, and management of internal and external partners to ensure that trial timelines, costs, and quality metrics were met.• Thorough understanding of Good Clinical Practices, Good Manufacturing Practices, and ICH GCP guidelines.• Demonstrated ability to work effectively in a cross-cultural matrix team environment.

Experience

1. Program Lead, Clinical Supply Operations Project Manager (Contract)

   The Evanston Group Now Eg Life Sciences

   Feb 2020 — Present · Basking Ridge, NJ, US

   Perform the role of Program Lead for Clinical Supply Operations*Assist in order to insure on-time delivery of clinical supplies for studies across the portfolio of products*Assume responsibility from both a lead position as well as hands on for ensuring assigned projects are manufactured, packages, labeled and distributed to time to support all phases (1-4) of required clinical studies*Develop and maintain study-level budgets*Work closely with Supply Planning and Logistics to ensure tasks and supply plans are executed in a timely manner and within budget*Evaluate, select, and implement contract manufacturing, packaging and labeling*Negotiate work orders/proposals, in collaboration with Supply Chain and Logistics and oversee operations*Act as primary liaison with clinical personnel on assigned projects*Participate in the design of overall clinical plans and study protocols. Recommend type and method of packaging, labeling and distribution. Translated protocol requirements and study milestones into an actionable Supply Plan Agreement*Recommend matching placebo drug sources*Assist in developing appropriate strategies for regulatory CMC filing (domestic and international)*Assist in identifying emerging trends, technologies, and best practices and implement as appropriate*Assist in the establishment of SOPs and guidelines related to production planning and scheduling, inventory management, distribution, transportation, disposition of returned/unused materials etc.

Education

• Drexel University's LeBow College of Business

  Bachelor of Science in Business Administration, Operations Management

  1987 — 1993

• Drexel University's LeBow College of Business

  Bachelor of Science - BS, Operations Management and Supervision

Skills

• Good Clinical Practice (Gcp)
• Clinical Research
• Clinical Development
• CRO
• Data Management
• Vaccines
• Regulatory Affairs
• U.s. Title 21 Cfr Part 11 Regulation
• Electronic Data Capture (Edc)
• Pharmaceutical Industry
• Sop
• Fda
• 21 Cfr Part 11
• Clinical Trials
• Logistics Management
• Gcp
• Edc
• Standard Operating Procedure (Sop)
• Ctms
• Ich-Gcp
• Oncology
• Protocol
• Gmp