Job Details

  • Title: Clinical Project Manager
  • Code: RCI-15653
  • Location: US-Remote
  • Posted Date: 01/14/2022
  • Duration: 12 Months
Talk to our Recruiter

  Job Description

Part-Time: 20-30 hrs./week

2 yrs. exp in  pharma industry ideally in clinical supply management

 

Clinical Project Manager I (Non-MD)

  • MD will not work for this role
  • GMP or GCP exp
  • Someone with IRT or IVRS or IWRS exp
  • Clinical label design exp
  • Exp with review of clinical protocols and translate them in to supply strategy
  • Someone with project management, inventory management or supply chain management
  • Project management planning, forecasting and inventory management
  • Degree in biology chemistry or engineering or pharmacy
  • Need to have a bachelor’s degree
  • No need of medical degree like MD
  • CRA or Clinical trials manager will also work if they have project management exp
  • Clinical operations management, drug development exp will also be considered
  • will be working in a matrix environment
  • Exp with clinical packaging
  • Knowledge of how to package drug or where the drug will be sent to
  • Exp with distribution management. shipment management
  • Familiarity with regulations in industry and clinical trials
  • Pharm D will work for this role
  • Project management experience
  • Medical device exp will be considered as well

Education Requirement:

  • Bachelor’s Degree required preferably in physical science, math, engineering or pharmacy.

Experience:

2+ years total experience in the Pharmaceutical Industry. Preferably experience in one of the following areas:

  • Drug discovery (eg, Process Chemistry, Analytical Chemistry)
  • Drug development (eg, Formulation)
  • Clinical operations (eg, Clinical Project Management)
  • Supply chain (eg, Clinical Supplies Project Management)
  • Quality Assurance

Major Responsibilities:

  • Responsible for the project management of key Clinical Supply Chain activities at the protocol level for pre-clinical and Phase I – III clinical trials
  • Includes forecasting, planning, scheduling, coordination and execution, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots.
  • Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient utilization of supply chain resources.
  • Translates clinical study design into packaging design. Authors the study medication and labeling section of the clinical protocol.
  • Develops protocol specific labeling compliant with applicable global regulations.
  • Identifies, develops, communicates and tracks project timelines, activities, logistics, and milestones.
  • Responsible for protocol specific clinical supplies scenario analysis, risk management and contingency planning. Forecasts protocol specific bulk drug product requirements, including comparator agents, ancillary supplies and commodities, including overages.

 Critical Success Factors

  • Understanding of clinical development and global supply chain requirements.
  • Competent in the application of standard business requirements (for example SOPs, Global Regulations).
  • Understanding the importance of compliance in a regulated environment and be capable of applying this knowledge to daily work.
  • Ability to work collaboratively within the dept as well as cross-functionally including interacting in a tactful, professional and effective manner.
  • Ability to work effectively and professionally with those in the dept as well as Clinical, QA, Analytical and any area interface.
  • Ability to manage and prioritize multiple tasks.
  • Project Management skills.
  • Good communication skills (both written and oral).