Clinical Research Manager

The recommended skills and qualifications for the CPM position include a BS degree or other relevant background, combined with minimum three years of clinical trial monitoring experience and strong organizational skills;
• Advanced negotiating and organizing competencies;
• Clinical Trial Management and Execution Skills;
• Business Process Skills;
• Resource Management Skills;
• Strong project management skills;
• Vendor Management;
• Manage the completion of all clinical trials with passion for continuous improvement;
• English proficiency;
• Availability to travel to sites.

The Clinical Project Manager (CPM) ensures that clinical trials Phase II trough Phase IV are effectively executed at a country/ sub-regional level, from pre-study through close – out activities.

Approximately 90% of the CPM’s time is devoted to core Clinical Operations activities. There include:

• Managing the Clinical Resource Organizations ( CROs) servicing trials within a country, in conjunction with the Head of Country / Su- Regional Clinical Operations (HCO);
• Ensuring clinical trials are effectively executed from pre-study through close-out activities;
• Ensuring trials are completed within budget, timeline, and enrollment commitments;
• Co-monitoring sites to track progress;
• Maintaining study budget;
• Ensuring all trials follow appropriate Standard Operating Procedures (SOPs);
• Ensuring regulatory documentation is properly maintained before starting study;
• Tracking drug and clinical suppliers to ensure that sites have the materials required to conduct the study effectively;
• Managing pre-selection and trial initiation activities;
• Performing trial close – out activities;
• Ensuring contract are in place.

Approximately 10% of the CPM’s time is involved in Medical Affairs activities, such as participating in brand and marketing review.