Clinical Trials Manager - School of Medicine, Nephrology
About the role
Manages the financial, regulatory, patient management, and human resources functions associated with conducting clinical trials. Typically supervises a staff of 2 - 5 employees/students. Coordinate with cross-functional teams to ensure the smooth execution of trials. Supervise site selection and initiation activities. Manage relationships with clinical sites and investigators. Participate in recruitment (multiple trials) and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements. Oversee data collection, analysis, and EDC data entry, train new clinical trials staff. Tracks enrollment/targets across all trials, sponsor payments, and salary. Provides leadership in business development. Responsible for preparing and routing all proposals and routing through the various Emory systems. Assists in creating and maintaining Standard Operating Procedures.
Responsibilities
- Manage financial, regulatory, patient management, and human resources functions associated with clinical trials.
- Supervise a staff of 2 - 5 employees/students.
- Coordinate with cross-functional teams to ensure the smooth execution of trials.
- Supervise site selection and initiation activities.
- Manage relationships with clinical sites and investigators.
- Participate in recruitment (multiple trials) and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements.
- Oversee data collection, analysis, and EDC data entry, train new clinical trials staff.
- Tracks enrollment/targets across all trials, sponsor payments, and salary.
- Provides leadership in business development.
- Prepare and route all proposals and route through the various Emory systems.
- Affix assistance in creating and maintaining Standard Operating Procedures.
Requirements
- A bachelor's degree in a related field and seven (7) years experience in clinical trials, two of which are in the clinical area.
- OR a master's degree and four years of experience in clinical trials, one of which is in the clinical area will be considered equivalent.
- Strong understanding of ICH-GCP guidelines, Certified Clinical Research Professional (CCRP) or equivalent (preferred).
Qualifications
Note: This role will be granted the opportunity to work from home regularly but must be able to commute to Emory University on a flexible weekly schedule based upon business needs. Schedule is based on agreed upon guidelines of department. This role requires residency in the state of GA.
Skills
Not specified.
Benefits
Not specified.
Pay
Not specified.