Clinical Project Manager II - Proxima Clinical Research

JOB SUMMARY 

Responsible for leading and coordinating cross functional project teams executing a clinical project or projects under the direct supervision of a more senior CPM or Project Director.  May be responsible for overseeing multiple projects or one larger project.  The position is expected to communicate cross-functionally with internal departments, Sponsors, vendors, suppliers, contractors, sites, and management on project related activities.  

May coordinate product development activities with other vendors and/or CROs. 

DUTIES AND RESPONSIBILITIES 

• Responsible for management of all operational, financial, and contractual aspects of assigned clinical studies including coordination and/or management of other vendors and liaison with other Proxima functional areas. 

• Plans and manages assigned clinical studies to ensure meeting of timelines, on-budget execution and adequate human resource allocation. 

• Monitors project budget vs. cost.  Responsible for reporting of project metrics, revenue recognition and for ensuring timely execution of change orders to ensure that the project margins are being met.   

• Proactively anticipates and understands concerns/issues/delays in the studies and develops risk assessment and contingency plans. 

• Participates in proposal development and bid defense meetings as assigned. 

• Participates in project kick-off meetings, routine study team meetings, provides regular updates to client, and ensures maintenance of communication between team members and client.   

• Ensures conduct of clinical studies in compliance with regulatory requirements and Good Clinical Practices (GCPs), and Proxima and/or client policies, procedures and development program. 

• Drafts study protocols, clinical study reports and other clinical documents. 

• Ensures team members have necessary resources to complete assigned tasks. 

• Provides input into performance management of project team including input. 

• Manages and tracks project team training. 

• Creates and promotes a positive team environment and project team productivity. 

• Reviews and approves client deliverables and study teamwork product prior to client submission 
  

  EDUCATION, TRAINING AND PRIOR EXPERIENCE REQUIREMENTS 

• Four-year degree in a project management, scientific or health related field.   

• 3+ year(s) experience as a Project Manager for a Clinical Research Organization (CRO) or Sponsor. 

• Knowledge of guidelines, FDA Code of Federal Regulations, Good Clinical Practices, and ICH Guidelines for the conduct of clinical trials. 

• Ability to travel approximately 20% both domestically and internationally.  

• KNOWLEDGE, SKILLS, AND ABILITIES 

• Ability to interpret study protocols and designs. 

• Strong leadership and interpersonal skills with strong attention to detail. 

• Knowledge and experience using project management methodologies and tools. 

• Excellent oral and written communication skills.   

• Understanding and experience in the clinical trial process. 

• Self-management and organizational skills  

• Ability to multi-task, meet rigorous timelines, and work effectively in stressful situations.   

• Good customer/client relationship management and proactive problem-solving skills.   

• Ability to maintain a high degree of confidentiality. 

• Technologically savvy.  

• Ability to maintain a high degree of confidentiality. 

• Technologically savvy.  

• Proficient in MS Office Products (Word, Excel, PowerPoint).