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.