Clinical Project Manager Job Description

Clinical Project Manager Job Description Template

Our company is looking for a Clinical Project Manager to join our team.

Responsibilities:

  • Develop protocol specific labeling compliant with applicable global regulations;
  • Responsible for protocol specific clinical supplies scenario analysis, risk management and contingency planning;
  • Provide input to Clinical Study Teams to influence clinical protocol design;
  • Forecast protocol specific bulk drug product requirements, including comparator agents, ancillary supplies and commodities, including overages;
  • Translate clinical study design into packaging design;
  • Initiates improvements to enhance the efficiency and the quality of the work performed on assigned projects;
  • Autoimmune & Rheumatology;
  • Reviews protocols and assists with development of project plans, DMPs and monitoring plans;
  • Manages day to day operations of the the current project;
  • Compiles and drives documentation for the project, ensures the accuracy and quality of regulatory data;
  • Monitoring team performance against contract, customer expectations, and project baselines;
  • Rare Blood Diseases (non-oncology) and Metabolic/Storage Disorders;
  • Manages outside vendors such as monitoring CRO, diagnostic companies, stats contractors, meeting planners, drug depots etc;
  • Develops project status reports and communicates with all applicable team members in and outside the organization;
  • Provide timely delivery of documents and services, all in accordance with relevant policies, procedures, and SOP’s.

Requirements:

  • Ability to prioritize and manage multiple tasks;
  • Project management skills;
  • Experience in Quality Assurance is highly preferred;
  • Understanding of clinical development and global supply chain requirements;
  • Bachelor’s Degree required preferably in physical science, math, engineering or pharmacy;
  • Ability to work collaboratively within the dept as well as cross-functionally including interacting in a tactful, professional and effective manner;
  • Proficient in Microsoft Office products;
  • Excellent written and verbal communication skills;
  • Ability to travel up to 5% of time;
  • Bachelor’s degree from an accredited four-year college or university in a biological program;
  • Two or more years of experience in project management;
  • Two or more years of experience in the clinical research industry or equivalent;
  • Detail oriented;
  • BS/BA in Psychology or Neuroscience;
  • MS in psychology or Neuroscience preferred.